Sr. Clinical Project Manager
About the position The Sr. Clinical Project Manager is a member of the Zenas Clinical Operations team and is responsible for the day-to-day operational management of one or more global clinical trials and oversight of CROs and clinical vendors. The CPM participates in a cross-functional team and partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timeline. This position reports to the Senior Director, Clinical Project Management.
Responsibilities
- Manages all operational aspects of one or more global clinical trials from start-up to close-out; proactively identifies and resolves operational issues to assure adherence to timelines, budget and milestones while ensuring compliance to applicable SOPs, guidelines, and regulations.
- Participates in planning and communication with cross functional teams within clinical development to ensure proper execution of clinical trials.
- Participates in evaluation and selection of clinical study vendors including CRO, Data Management, IRT, Central labs, Imaging, etc.
- Manages and provides day-to-day oversight of CROs and third-party vendors including set-up, logistics, documentation, and clinical supplies needed for clinical trial(s)
- Responsible for the trial level clinical operations budget, invoices, and change orders.
- Participates in patient recruitment planning collaborates with Clinical Site Management on activities to meet study enrollment goals and timelines.
- Develops and maintains study timelines, enrollment dashboards and status reports for senior management and reports on issues as required.
- Contributes to the development of clinical documentation including but not limited to study protocols, informed consents, Study Reference Binder, study level plans and manuals and training materials.
- Participates in the development and design of CRFs and CRF Completion Guidelines, including participating in the EDC and IXRS specification process and UAT.
- Contributes to and may lead the development of presentations for clinical sites, team and investigator meetings.
- May assist with the development of any new or updated SOPs/processes for the clinical department.
- Trains, mentors and may manage junior team members.
- May participate in departmental initiatives Requirements
- B.A. or B.S. degree, preferably in a scientific discipline
- A minimum of 7 years of industry experience in the pharmaceutical industry or equivalent, plus 4+ years of trial management experience managing study teams for phase I, II or III studies. Multi-country global study experience is required.
- Prior experience in management of CROs
- Experience with clinical study budgets,
- Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process.
- Independently motivated, detail oriented and good problem-solving ability. Ability to make independent, timely, and risk-based decisions
- Excellent written and verbal communication skills.
- Experience interacting with key functional stakeholders (clinical development, regulatory, QA, supply chain)
- Comfortable working in a demanding, fast-paced, start-up culture with evolving processes. Flexible and able to adapt to new situations as the business demands.
- Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.
- Ability to travel domestically and internationally (minimum of 25%) including travel to the office a minimum of 6 times a year if not based locally.
Benefits
- The position is eligible for a competitive compensation and benefits package.
- Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans. Apply tot his job
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