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About PanCAN Pancreatic cancer doesn’t stop or slow down, and neither do we. At the Pancreatic Cancer Action Network (PanCAN), weaccelerate critical progress for pancreatic cancer patients. We take bold action by funding life-saving research, providingpersonalized patient services free of charge, and creating acommunity of supporters and volunteers who will stop atnothing to create a world in which all pancreatic cancer patientsthrive.                             PanCAN’s Precision Promise(SM) is one example of howwe work to change the future for pancreatic cancer patients.Precision Promise(SM) is our groundbreaking clinical trial platformthat is now enrolling patients at top institutions nationwide.Precision Promise(SM) is what the pancreatic cancer field and ourpatient community have been waiting for, hailed for its ability totransform the way clinical research is done for this disease.We’re looking for people who, like us, will stop at nothing tomake progress for patients. Our work is critical and meaningful,and it changes lives every day. Join us and be a part of it!THE OFFER:  To support the people fighting theworld’s toughest cancer, we provide our staff with the resources,care, and sparkle to do and be their best in and out of theoffice. We offer competitive salaries, flexible work arrangements,exceptional time off, and health and welfare benefits creating anextraordinary workplace, total rewards package, and culturethat our team members highly recommend to friends andcolleagues. We’re looking for people who, like us, will stop at nothing tomake progress for patients. Our work is critical and meaningful,and it changes lives every day.  Join us, be a part of it, and workremotely from anywhere! THE OPPORTUNITY Reporting to the Vice President of Leadership Giving, the NationalDirector of Leadership Giving will lead all major gifts fundraisingin their assigned U.S. region. The position is a remote positionfor the Northeast Region and requires a deep understanding of thephilanthropic landscape and community in the assigned region. TheNational Director will be expected to build and manage a portfolioof donors and prospects with the potential to make six-figure andseven-figure gifts to support research, clinical initiatives,patient services, advocacy efforts and other key priorities. TheNational Director of Leadership Giving will bring an accomplishedtrack record of establishing and growing major giving programs andwill contribute to PanCAN’s overall goal to increase theorganization’s annual revenue to $80M. ESSSENTIAL FUNCTIONS <ul><li>Develop and implement an integrated strategic cultivation planthat will generate major gifts from high-level, sophisticateddonors and prospects within the assigned region.</li><li>Identify, qualify, cultivate, solicit, and steward major giftprospects that meet and exceed all activity metrics and revenuegoals.</li><li>Build a strong portfolio of new donors and prospects thatgenerates six-figure gifts from a wide range of sources.</li><li>Build and maintain a strong portfolio of 100-125 current andnew donors and prospects, utilizing senior PanCAN executives, boardmembers, and volunteers as natural partners in cultivating andsoliciting gifts.</li><li>Develop and maintain positive, collaborative workingrelationships with the development and community engagementteams.</li><li>Cultivate planned giving relationships that create a pipelineof new and existing donors as part of the Micki Love Society,PanCAN’s legacy giving program.</li><li>Act as principal donor strategist for each prospect in theportfolio with specific responsibility to develop a written donorstrategy and relationship record of all interactions. </li></ul>MAJOR OBJECTIVES Within the first 12 to 18 months, the National Director ofLeadership Giving will achieve the following major objectives:<ul><li>Generate from the portfolio at least three to five major giftsat the six-figure level, with a goal of raising at least $2 to $3million annually within the next three years.</li><li>Build a broad base of support for long-term sustainablerevenues through PanCAN’s medical and scientific leadership.</li><li>Work closely with the Development, Community Engagement, andPanCAN Patient Services teams to develop successful donorpartnerships with patients and families.</li></ul>QUALIFICATIONS &amp; REQUIREMENTS<ul><li>A deep, passionate commitment to the Pancreatic Cancer ActionNetwork.</li><li>A minimum of five to seven years of successful fundraising(major gift) experience in managing high-level donor and prospectrelationships with a proven record of soliciting major gifts at thesix-figure level or seven-figure level. Experience with major giftsin a healthcare environment would be an advantage.</li><li>A proactive, transparent leader with the maturity, discipline,and drive to build new and existing donor and prospectrelationships.</li><li>A strong listener with the tact and sensitivity to engage wellwith a diverse range of donors, volunteers, patients, andfamilies.</li><li>Capacity to acquire an understanding of pancreatic cancer, aswell as issues regarding biomedical research, clinical studies, andpatient services.</li><li>Strong interpersonal and motivational skills that convey trust,flexibility, and integrity with the ability to communicateeffectively and concisely, both in writing and orally; listen aswell as give advice; and respect the ability of others.</li><li>Outstanding organizational skills and ability to managemultiple tasks simultaneously and meet deadlines and goals.</li><li>Excellent communication and verbal skills with a persuasiveability to generate support on behalf of PanCAN.</li><li>Ability to partner closely with senior leaders across theorganization, including the CEO and executive leadership.</li><li>Experience working effectively and respectfully as part of acommitted, integrated Development team.</li><li>Strong research, planning, analytical, and problem-solvingskills, and an ability to effectively screen prospective donorsfrom information provided by PanCAN leaders and volunteers.</li><li>High degree of technological proficiency with top fundraisingsoftware such as The Raiser’s Edge.</li><li>Ability to travel for donor visits and attend activities asneeded, including evenings and weekends.</li><li>A bachelor’s degree from an accredited university or college isrequired.</li></ul>SALARY RANGE: ($140-185k) PanCAN iscommitted to providing fair and transparent employeepay.  Our compensation policy and practicesintegrate years ofrelative experience, skills, job duties,functions, responsibilities, education, certifications, expertise,PanCAN seniority, position/title, department,market conditions, and merit, andmay also include geographic location.  Ourbase salaries range from Entry level to Experienced andmax at Expert level.  The base pay range includedherein is specific and germane to thejob/position/opening as described withinthis announcement.  EXPECTATIONS FOR ALL EMPLOYEES: Support the organization’s mission and goals by exhibiting thefollowing core values:  Deliver Excellence, Service &amp;Gratitude, Accountability, Team, and SparkleSpirit!  Individuals assigned to this position must beable to work in a fast-paced, deadline-driven environment withdemonstrated ability to juggle and prioritize multiple, competingtasks and demands and to seek management assistance asappropriate. GENERAL INFORMATION: The above statements are intended to describe the general natureand level of work being performed by individuals assigned to thisposition. They are not intended to be an exhaustive list of allrequired duties, responsibilities, and skills.   ThePancreatic Cancer Action Network is an equal opportunity employerand affords equal opportunity to all applicants for all positionswithout regard to race, color, religion, gender, national origin,age, disability, veteran status, or any other status protectedunder local, state, or federal laws.Note: A cover letter is required with yourresume

National Director, Leadership Giving (Northeast US Region) Remote

Piper Companies is currently seeking a Clinical Trial Manager to join the FSP Group of a global clinical research organization that is dedicated to supporting successful in vitro diagnostics clinical trials.




Responsibilities of the Clinical Trial Manager:

Manage all activities to support delivery and execution of clinical trials
Conduct project resourcing to ensure project deliverables are met
Ensure project is completed within compliance, timeline and budget
Provide project updates and status reports with internal and external stakeholders
Coordinate project and therapeutic training and development

Qualifications of the Clinical Trial Manager:

4+ years relevant experience within a pharmaceutical company or CRO
3+ years clinical project or trial management experience
Prior experience managing In Vitro Diagnostic complex or global trials required
Bachelor’s degree or equivalent experience required

 Compensation for the Clinical Trial Manager:

Salary Range: $135,000 - $150,000 based on experience
Benefits: Competitive comprehensive benefits package included

Keywords: Clinical Trial Manager, CTM, Clinical Trial Lead, CTL, Clinical Project Manager, CPM, Clinical Manager, Clinical Project, Project Manager, Senior Project Manager, SPM, Regulatory, Regulatory Affairs, Clinical Operations, Biometrics, Medical Affairs, Medical Safety, Clinical Research, Clinical Trials, CRO, Neuro, Pediatrics, Biopharmaceutical, Biopharma, Pharmaceutical, Pharma, Medical Device, Therapeutics, Health, Dental, Vision, Retirement, Benefits, Remote, In Vitro, In Vitro Diagnostics, IVD, FSP

Clinical Trial Manager

Clinical Trial Manager - In Vitro Diagnostics (Remote)

Piper Companies is currently seeking a Senior Clinical Trial Manager for an opportunity in Scottsdale, Arizona (AZ). The Senior Clinical Trial manager will participate in ongoing Clinical Trials throughout the Country for a leading Clinical Research Organization. 

 

Responsibilities for the Senior Clinical Trial Manager:

Manages the Clinical and Site Management of assigned projects
Leads global study and reviews scope of work, budget, and protocol content
Understands scope of project, risk management, and compliance of overall study
Position is fully remote with no travel required

Qualifications for the Senior Clinical Trial Manager:

 3+ years of full scope trial management
 Experience with multiple therapeutic areas is advantageous
 Organization to perform monitoring duties across multiple sites is a must




 Compensation for the Senior Clinical Trial Manager

Salary Range: $135,000-$160,000
Comprehensive Benefits: Medical , Dental, Vision, and 401K

Senior Clinical Trial Manager

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s  Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&amp;D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&amp;D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Manager/Senior Manager, Clinical Data Validation Engineer where you will work with Data engineering team, standards and Clinical Data Management teams in the development of data cleaning/quality checks, study status metrics, visualizations and monitoring reports standards. You will also lead and organize programming activities for assigned clinical studies and non-clinical data cleaning activities. Develop parameterized data cleaning reports to support data review plan.

How you will contribute:

Create data cleaning reporting solutions with appropriate oversight that support the quality and timely delivery of data cleaning, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 
Create any needed documentation for reports throughout the lifespan of the study and/or asset for all deliverables 
Develop library of reusable checks working closely with data engineers and config specialists.
Collaborate with cross functional teams in creating business rules and automated check library across TAU.
Develop SOPs and working practices for the team.
Complies with applicable SOPs and work practices 
Serves as a technical resource for creating data analytics to help with data validation and cleaning
Supports knowledge development of others on reporting tools that support the accuracy and integrity of study data 
Provide programming expertise for data cleaning to efficiently ensure high quality data 
Enhances available reporting tools/macros/libraries or creates new ones to support the review of clinical trial data and trial status information for cross-functional use and provides input on data management reporting standards as required 
Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 
Creates and tests listings for data review. 
Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 
Ensures operational excellence in collaboration with partners and colleagues for application of standards and develop data cleaning reports in support of the data review plan, in collaboration with the Clinical Data Management and medical reviewers
Directly supports knowledge development of others on data reporting and reporting tools that support the accuracy and integrity of study data 
Identifies existing process/product improvements 
Develops innovative, advanced new concepts that improve processes 
Recognizes development needs and identifies/creates development opportunities within team 
Supports the development of the Data Management Programming talent base and identifies development needs within the area of responsibility 
Ability to setup and configure analytics for coding reports, safety review and any risk-based monitoring activities

Minimum Requirements/Qualifications:

MS with ~ 6+ years of industry related experience for Senior Manager.
BS with ~ 8+ years of industry related experience for Senior Manager.
BS with ~ 5+ years of industry related experience for Manager.
Advanced degree preferred.
Proven track record of contributing to business process transformation and organizational culture change as well as providing programming expertise on programs with complex business deliverables 
Experience leading business process transformations and organizational culture change as well as contributing to programming expertise on programs with complex business deliverables 
Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 
Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 
Strong communication (written and oral), leadership, decision-making, influencing, negotiation, and project management skills 
Demonstrated experience managing complex projects and developing successful partnerships within and across functional areas 
Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle),
EDC build and/or clinical data management experience preferred 
Experience in AWS preferred
Experience setting up automated validation is preferred
Knowledge of Data lake and creating interactive Dashboards are preferred
Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) 
Programming, specifically SAS, Python and R, and other visualization tools hands-on experience (BOXI, Spotfire, Tableau, RShiny, JReview, Plotly, Elluminate) 

What Takeda can offer you:

Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning &amp; Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health &amp; Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Flexible Work Paths
Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
Preference will be given to candidates with a remote location near the corporate office in Boston, Massachusetts.
Base Salary Range: $102,200 to $146,000 based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days &amp; Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts - VirtualWorker Type

EmployeeWorker Sub-Type

RegularTime Type

Full time  #LI-Remote

114 Remote Clinical Trial Manager Jobs