<h3>Job Description</h3>
Job Description
Position Summary:
The Clinical Trial Manager is responsible for the overall management, planning, implementation, and execution of clinical trial(s) in a fast-paced environment with moderate oversight from the Senior Clinical Trial Managers and/or Associate Director, Clinical Operations.
Preferred job location: Waltham, MA. Remote candidates will be considered on a case-by-case basis or relocation may be provided.
Key Responsibilities Include:
<ul>
<li>Leads and/or assists the trial team to execute and deliver the clinical trial in accordance with the clinical development plan/strategy, budget and timeline.</li>
<li>Author clinical trial documents and trial-related plans.</li>
<li>Contributes to and/or approves with oversight, the clinical review of CRFs, CRF completion guidelines, and the data review plan.</li>
<li>Leads/assists in the identification and selection of investigator sites.</li>
<li>Responsible for planning, conducting, and presenting during Investigator's Meetings.</li>
<li>Provides input and coordinates the delivery of clinical trial supplies in collaboration with Clinical Supply team as escalate issues as appropriate.</li>
<li>Collaborates with the cross-functional team on selection and management of clinical trial vendors.</li>
<li>Responsible for providing input to Trial Master File Plan, overseeing Clinical Operations-related documentation, and coordinates with document specialists regarding trial files.</li>
<li>Manages and triages escalation of trial-related issues and communicates as appropriate with management and other cross-functional areas.</li>
<li>Leads oversight of CRO activities and other clinical vendors to ensure the quality meets Apellis and regulatory requirements.</li>
<li>Monitors and manages budget for clinical trial(s) including proposals, contracts, and change orders from CROs and vendors.</li>
<li>Attend periodic visits to sites and/or CROs to assess progress of trials/protocol compliance.</li>
<li>Reviews clinical monitoring reports and correspondence related to monitoring visits, identifies issues/trends as available, and provide oversight and/or serve as escalation point to junior team members.</li>
<li>Collaborate with cross-functional team members to monitor the clinical trial data to ensure timely entry, collection, and identification of data quality issues.</li>
<li>Provides periodic status reports regarding trial timelines, budget issues, accruals, etc. to management as requested.</li>
<li>Responsible for managing one or more clinical trial(s).</li>
<li>Support departmental initiatives and process improvements.</li>
<li>Provides input and serves as the subject matter expert for the trial during regulatory inspections.</li>
<li>Other duties and responsibilities as required.</li>
</ul>
Education, Registration &amp; Certification:
<ul>
<li>B.S/B.A. degree is required. Science/health care related field preferred but not required.</li>
</ul>
Experience:
<ul>
<li>5+ years' experience working within a pharmaceutical/biotech company, CRO, or similar organization.</li>
<li>2+ years' experience managing clinical trials.</li>
<li>Ophthalmology, Nephrology, Hematology experience preferred. </li>
</ul>
Skills, Knowledge &amp; Abilities:
<ul>
<li>Must be able to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands.</li>
<li>Ability to complete tasks to deadlines (time management) and resolve/escalate problems in a timely manner.</li>
<li>Excellent written and verbal communication skills required.</li>
<li>Provide review of vendor requests for proposals, scope of work(s), and contract scope changes.</li>
<li>Contribute, develop, and manage clinical trial budget(s).</li>
<li>Strong knowledge of applicable computer and project management software packages, including Microsoft Suite.</li>
<li>Knowledge of current regulatory requirements and guidelines governing clinical research and related terminology.</li>
<li>Ensure trial adherence to ICH/GCP/local regulations.</li>
<li>Lead a cross-functional team within an evolving organization and external vendors.</li>
</ul>
Physical Demands and Work Environment:
This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Travel Requirements:
<ul>
<li>Up to 25% domestic and/or international travel.</li>
</ul>
Benefits and Perks:
Base salary for this role will consider multiple factors, including but not limited to, candidate qualifications, relevant expertise, specialized skills, and industry experience in complement-targeted therapies.
The targeted base salary range for this position is $128,000- $191,000 per year. This range represents the base salary only and reflects Apellis' commitment to competitive compensation within the biopharmaceutical industry. The final salary offered may vary based on individual qualifications, business needs, and current market conditions.
Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit <a href="https://apellis.com/careers/benefits/" target="_blank">https://apellis.com/careers/benefits/</a> to learn more.
Company Background:
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.
For more information, please visit <a href="http://apellis.com" target="_blank">http://apellis.com</a> or follow us on Twitter and LinkedIn
EEO Statement:
Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.
For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. 
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Clinical Trial Manager

<h3>Job Description</h3>
Job Description
Position: &nbsp;Clinical Research Associate Location: Remote Role - must be willing to come onsite occasionally at San Diego, CA, 92123 Client: Leading Medical Devices Manufacturer Duration: 6 months contract Payrate: $35 - $45/hour &nbsp;
Role Purpose This role supports the Medical Affairs team during a maternity leave coverage. The team is focused on clinical trials and evidence generation for innovative health technologies beyond traditional sleep apnea solutions, including insomnia and neurostimulation. Key Responsibilities
<ul>
<li>Clinical Trial Support:
<ul>
<li>Site coordination (equipment, documentation, queries)</li>
<li>Trial monitoring for data accuracy and compliance</li>
<li>Occasional travel for site setup/training (minimal expected)</li>
</ul>
</li>
<li>Documentation &amp; Organization:
<ul>
<li>Maintain master files, smart sheets, and trial records</li>
<li>Ensure proper filing and traceability</li>
</ul>
</li>
<li>Patient Registry Management:
<ul>
<li>Oversee ResMed’s clinical trial registry (focus on insomnia patients)</li>
<li>Support recruitment campaigns and participant data management</li>
<li>Coordinate simple studies (e.g., surveys, equipment mailing)</li>
</ul>
</li>
<li>Patient Interaction:
<ul>
<li>Communicate with trial participants in a professional and personable manner</li>
</ul>
</li>
</ul>
&nbsp; Job Description: The primary role of Clinical Studies and Development is the oversight, administration, and execution of the approved clinical study plan. This will include all aspects of the execution of the study, such as contracting, documentation, site visits, and report writing. This role may be as a Study Manager, Clinical Trials Associate, or other similar role. Let’s talk about Responsibilities
<ul>
<li>The primary objective of Clinical Research (CSD) specialization within Clinical Studies &amp; Development Job Family is to oversee and develop clinical projects including research studies in relation to product development.</li>
<li>Provides strategic input and development support for clinical plans and individual study protocols.</li>
<li>Participates in the development of clinical operating guides and maintains secure study files.</li>
<li>Reviews results of these studies with appropriate management prior to publication.</li>
<li>Demonstrates appropriate technical proficiency, scientific creativity, collaboration with others and independent thought.</li>
<li>.</li>
<li>Performs work in a specialized area of expertise that requires knowledge of fundamental themes, principles and concepts. Typically requires a university degree or equivalent work experience.</li>
<li>Responsibilities might include:</li>
<li>(1) Performing routine professional-based activities (early in career)</li>
<li>(2) Contributing to and managing projects (mid-career)</li>
<li>(3) Providing advice/direction in primary areas of expertise (specialist and expert)</li>
<li>(4) Leveraging professional expertise and relationships to contribute to strategy and drive business results (principal)relationships to contribute to strategy and drive business results (principal)</li>
<li>Builds stable working relationships internally to exchange information.</li>
<li>Receives instruction, guidance and direction from others.</li>
</ul>
 Let’s talk about Qualifications and Experience Required: Preferred:
<ul>
<li>Bachelor’s degree.</li>
<li>Minimum of 2 years of related experience.</li>
<li>Follows standard practices and procedures and applies basic theories, concepts, principles and methodologies in analyzing situations or data.</li>
</ul>
Company DescriptionDella Infotech Inc is in the staffing business for 10 years. Over the years, we have placed hundreds of candidates to various temp and permanent positions with our 50+ happy clients all over US and Canada including Fortune 500 corporations. 
<h3>Company Description</h3>
Della Infotech Inc is in the staffing business for 10 years. Over the years, we have placed hundreds of candidates to various temp and permanent positions with our 50+ happy clients all over US and Canada including Fortune 500 corporations.

Clinical Research Associate (Clinical Trial) - Remote

<h3>Job Description</h3>
Job Description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on LinkedIn.
Responsibilities:
<ul>
<li>Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.</li>
<li>Demonstrated ability to lead/ manage multiple individuals and/or groups.</li>
<li>Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target.</li>
<li>Strategically assesses resource utilization and forecasting to ensure companywide goals are met</li>
<li>Effectively communicates complex strategic concepts with ability to tailor message to targeted audience.</li>
<li>Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.</li>
<li>Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment.</li>
<li>Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance.</li>
<li>Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans.</li>
<li>Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.</li>
<li>Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams.</li>
<li>Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.</li>
<li>Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals.&nbsp;</li>
</ul>
Requirements:&nbsp;
<ul>
<li>Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.</li>
<li>Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role</li>
<li>At least 5 years of experience in a CRO environment.</li>
<li>Demonstrated managerial skills and experience preferred.</li>
<li>High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines.</li>
<li>Excellent scientific writing skills.</li>
<li>Excellent analytical, organizational, and problem-solving skills.</li>
<li>Proficiency with MS Office applications.</li>
<li>Strong communication and presentation skills.</li>
<li>Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements</li>
<li>Understanding of CROs and scientific &amp; clinical data/ terminology, &amp; the drug development process.</li>
</ul>
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0nzcKKEdR0

Senior Manager, Clinical Trial Transparency & Disclosure (Remote)

<h3>Job Description</h3>
Job Description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on LinkedIn.
Responsibilities:
<ul>
<li>Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.</li>
<li>Demonstrated ability to lead/ manage multiple individuals and/or groups.</li>
<li>Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target.</li>
<li>Strategically assesses resource utilization and forecasting to ensure companywide goals are met</li>
<li>Effectively communicates complex strategic concepts with ability to tailor message to targeted audience.</li>
<li>Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.</li>
<li>Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment.</li>
<li>Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance.</li>
<li>Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans.</li>
<li>Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.</li>
<li>Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams.</li>
<li>Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.</li>
<li>Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals.&nbsp;</li>
</ul>
Requirements:&nbsp;
<ul>
<li>Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.</li>
<li>Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role</li>
<li>At least 5 years of experience in a CRO environment.</li>
<li>Demonstrated managerial skills and experience preferred.</li>
<li>High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines.</li>
<li>Excellent scientific writing skills.</li>
<li>Excellent analytical, organizational, and problem-solving skills.</li>
<li>Proficiency with MS Office applications.</li>
<li>Strong communication and presentation skills.</li>
<li>Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements</li>
<li>Understanding of CROs and scientific &amp; clinical data/ terminology, &amp; the drug development process.</li>
</ul>
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2iASYn1p8I

<h3>Job Description</h3>
Job Description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on LinkedIn.
Responsibilities:
<ul>
<li>Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.</li>
<li>Demonstrated ability to lead/ manage multiple individuals and/or groups.</li>
<li>Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target.</li>
<li>Strategically assesses resource utilization and forecasting to ensure companywide goals are met</li>
<li>Effectively communicates complex strategic concepts with ability to tailor message to targeted audience.</li>
<li>Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.</li>
<li>Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment.</li>
<li>Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance.</li>
<li>Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans.</li>
<li>Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.</li>
<li>Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams.</li>
<li>Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.</li>
<li>Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals.&nbsp;</li>
</ul>
Requirements:&nbsp;
<ul>
<li>Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.</li>
<li>Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role</li>
<li>At least 5 years of experience in a CRO environment.</li>
<li>Demonstrated managerial skills and experience preferred.</li>
<li>High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines.</li>
<li>Excellent scientific writing skills.</li>
<li>Excellent analytical, organizational, and problem-solving skills.</li>
<li>Proficiency with MS Office applications.</li>
<li>Strong communication and presentation skills.</li>
<li>Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements</li>
<li>Understanding of CROs and scientific &amp; clinical data/ terminology, &amp; the drug development process.</li>
</ul>
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lhGtpGUyMi

<h3>Job Description</h3>
Job Description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit&nbsp;<a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on&nbsp;LinkedIn.
Responsibilities:
<ul>
<li>Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.</li>
<li>Demonstrated ability to lead/ manage multiple individuals and/or groups.</li>
<li>Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target.</li>
<li>Strategically assesses resource utilization and forecasting to ensure companywide goals are met</li>
<li>Effectively communicates complex strategic concepts with ability to tailor message to targeted audience.</li>
<li>Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.</li>
<li>Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment.</li>
<li>Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance.</li>
<li>Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans.</li>
<li>Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.</li>
<li>Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams.</li>
<li>Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.</li>
<li>Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals.&nbsp;</li>
</ul>
Requirements:&nbsp;
<ul>
<li>Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.</li>
<li>Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role</li>
<li>At least 5 years of experience in a CRO environment.</li>
<li>Demonstrated managerial skills and experience preferred.</li>
<li>High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines.</li>
<li>Excellent scientific writing skills.</li>
<li>Excellent analytical, organizational, and problem-solving skills.</li>
<li>Proficiency with MS Office applications.</li>
<li>Strong communication and presentation skills.</li>
<li>Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements</li>
<li>Understanding of CROs and scientific &amp; clinical data/ terminology, &amp; the drug development process.</li>
</ul>
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cTExMoQFX9

<h3>Job Description</h3>
Job Description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on LinkedIn.
Responsibilities:
<ul>
<li>Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.</li>
<li>Demonstrated ability to lead/ manage multiple individuals and/or groups.</li>
<li>Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target.</li>
<li>Strategically assesses resource utilization and forecasting to ensure companywide goals are met</li>
<li>Effectively communicates complex strategic concepts with ability to tailor message to targeted audience.</li>
<li>Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.</li>
<li>Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment.</li>
<li>Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance.</li>
<li>Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans.</li>
<li>Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.</li>
<li>Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams.</li>
<li>Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.</li>
<li>Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals.&nbsp;</li>
</ul>
Requirements:&nbsp;
<ul>
<li>Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.</li>
<li>Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role</li>
<li>At least 5 years of experience in a CRO environment.</li>
<li>Demonstrated managerial skills and experience preferred.</li>
<li>High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines.</li>
<li>Excellent scientific writing skills.</li>
<li>Excellent analytical, organizational, and problem-solving skills.</li>
<li>Proficiency with MS Office applications.</li>
<li>Strong communication and presentation skills.</li>
<li>Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements</li>
<li>Understanding of CROs and scientific &amp; clinical data/ terminology, &amp; the drug development process.</li>
</ul>
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VU02WEQDgI

<h3>Job Description</h3>
Job Description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on LinkedIn.
Responsibilities:
<ul>
<li>Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.</li>
<li>Demonstrated ability to lead/ manage multiple individuals and/or groups.</li>
<li>Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target.</li>
<li>Strategically assesses resource utilization and forecasting to ensure companywide goals are met</li>
<li>Effectively communicates complex strategic concepts with ability to tailor message to targeted audience.</li>
<li>Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.</li>
<li>Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment.</li>
<li>Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance.</li>
<li>Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans.</li>
<li>Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.</li>
<li>Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams.</li>
<li>Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.</li>
<li>Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals.&nbsp;</li>
</ul>
Requirements:&nbsp;
<ul>
<li>Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.</li>
<li>Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role</li>
<li>At least 5 years of experience in a CRO environment.</li>
<li>Demonstrated managerial skills and experience preferred.</li>
<li>High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines.</li>
<li>Excellent scientific writing skills.</li>
<li>Excellent analytical, organizational, and problem-solving skills.</li>
<li>Proficiency with MS Office applications.</li>
<li>Strong communication and presentation skills.</li>
<li>Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements</li>
<li>Understanding of CROs and scientific &amp; clinical data/ terminology, &amp; the drug development process.</li>
</ul>
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<h3>Job Description</h3>
Job Description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on LinkedIn.
Responsibilities:
<ul>
<li>Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.</li>
<li>Demonstrated ability to lead/ manage multiple individuals and/or groups.</li>
<li>Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target.</li>
<li>Strategically assesses resource utilization and forecasting to ensure companywide goals are met</li>
<li>Effectively communicates complex strategic concepts with ability to tailor message to targeted audience.</li>
<li>Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.</li>
<li>Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment.</li>
<li>Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance.</li>
<li>Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans.</li>
<li>Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.</li>
<li>Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams.</li>
<li>Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.</li>
<li>Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals.&nbsp;</li>
</ul>
Requirements:&nbsp;
<ul>
<li>Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.</li>
<li>Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role</li>
<li>At least 5 years of experience in a CRO environment.</li>
<li>Demonstrated managerial skills and experience preferred.</li>
<li>High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines.</li>
<li>Excellent scientific writing skills.</li>
<li>Excellent analytical, organizational, and problem-solving skills.</li>
<li>Proficiency with MS Office applications.</li>
<li>Strong communication and presentation skills.</li>
<li>Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements</li>
<li>Understanding of CROs and scientific &amp; clinical data/ terminology, &amp; the drug development process.</li>
</ul>
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175 Remote Clinical Trial Manager Jobs