Clinical Trial Project Manager - BB14026
Job Description
Job Description
Clinical Trial Project Manager – BB14026
Remote
6+ Months
Remote (must be available for meetings between 7 AM–6 PM PT; one potential on-site workshop in Thousand Oaks in September)
contract through till end of year.
The ideal candidate has at least 5 years of project or program management experience within the biotech or pharmaceutical industry. They possess strong organizational and communication skills, are confident navigating complex, matrixed environments, and can juggle multiple priorities under tight timelines. This individual should be familiar with clinical trial operations (experience with decentralized trials is a plus), and have a proven ability to manage stakeholders, vendors, budgets, and project plans. A bachelor’s degree is required, while an MBA or PMP certification is preferred but not mandatory. This is a high-visibility, fast-paced role with an urgent need to fill, supporting two enterprise-level initiatives, including a national patient-facing health platform. Candidates must be flexible with scheduling across time zones and able to attend one on-site workshop in Thousand Oaks in September.
Seeking an experienced project manager to support key, high profile, fast paced, complex Digital Medicine programs and projects, including the Decentralized Clinical Trials project and The PARC program.
Primary Projects Supported
Decentralized Clinical Trials (DCT)
Highly visible project (1 level down from the CEO), Includes six workstreams
Responsibilities:
Meeting scheduling & facilitation
Agenda creation, risk identification, change management
Cross-workstream coordination
Functional reporting to another colleague (Soona)
The PARC Website (Patient-facing Cardiovascular Site), External-facing public health site
Responsibilities:
Traditional PM tasks (minutes, scheduling, risk tracking)
Budget and vendor management
Liaison role between internal strategy owners and external vendor
Basic Qualifications
Doctorate degree or Master’s degree and 2 years of experience or Bachelor’s degree and 4 years of experience or Associate’s degree and 8 years of experience or High school diploma / GED and 10 years of experience
Top 3 Must Have Skill Sets:
Project Management
Program Management
Communication Skills
Day to Day Responsibilities:
Decentralized Clinical Trials Project (75% time for 8-12 months)
Program Planning & Coordination
- Continue project and workstream startup activities including evolving workstream chartering and scoping, stakeholder identification, and project and workstream RACI development
- Support the end-to-end project lifecycle for defining processes and programs for Client decentralized and pragmatic trials methodologies
- Develop detailed project plan, timelines and milestones for overall project and workstreams aligned with project objectives
- Act as thought partner to task force leads to help identify relationships and synergies in activities of the workstreams
- Operational Execution
- Coordinate cross-functional meetings and decision-making across multiple functions; manage meetings including developing agendas, meeting facilitation and follow up/actions tracking
- Manage external vendors for timely, budget-compliant delivery
- Define and report success measures, workstream metrics management and reporting
- Track lessons learned and debrief with task force workstream leads at project close
- SOW and budgetary management
Risk & Issue ManagementCommunication & DocumentationThe PARC Program (25% time for 8-12 months)Project management1. Manage projects using proven PM tools and techniques for the operational aspects of the program2. Support program lead with all operational and PM activities3. Mange meetings including setting agendas, scheduling meetings, taking notes and action items and ensuring actions are completed/resolved.4. Identify and mitigate/resolve risks and issues5. Track timelines6. Report program milestones and achievementsTechnology team partnership1. Help ensure technology workplans are clear and concise and translatable to the business2. Participate in Client platform buildout sessions3. Partner with technology representative to track and report accomplishments, milestones and mitigate/resolve risks and issues.MAC process1. Own and execute the legal, medical and regulatory (LMR) process to manage cross-business unit material submissions and approvals.2. Be trained and versed in MAC processes3. Provide materials to relevant compliance, legal, regulatory and privacy points of contact for feedback prior to submitting to MAC4. Work with LMR staff to ensure jobs are submitted properlySOW development, financial and budget management1. Work with all vendors and program leads to ensure SOWs are properly written and executed2. Track all budget-related items for The PARC and report spending to function operations director3. Process and approve invoicesVendor Management (platform vendor)1. Translate business needs from Client’s PARC team into action items for the vendor to act on including completing project request forms, obtaining quotes to open POs, coordinating review and approval by the vendor and Client teams2. Develop SOWs, track and manage budgets3. Metrics and reportinga. Monitor weekly vendor dashboardsb. Report operational milestones and achievements4. Partner with vendor PM fora. Risk and issue identification and resolutionb. Timeline tracking
- Identify and mitigate project risks related to regulatory, operational, and technical challenges
- Drive issue resolution and track actions to closure
- Partner with task force and workstream leads to develop and cascade information among the workstreams and to stakeholders
- Prepare executive updates, summaries, dashboards, and report-outs
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