Senior Clinical Project Manager: Orelabrutinib
Zenas BioPharma
19 days ago
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Position Summary:
The Sr. CPM is the Global Project Lead for a Phase 3 Multiple Sclerosis study, responsible for day-to-day operational management of the trial and oversight of CROs and clinical vendors. Reports to the Senior Director, Clinical Project Management.
Key Responsibilities:
- Manage all operational aspects of a global clinical trial from start-up to close-out; identify and resolve operational issues to meet timelines, budget, milestones, and applicable SOPs, guidelines, and regulations.
- Partner with cross-functional clinical development teams to ensure proper execution.
- Chair internal Study Team Meetings.
- Participate in evaluation and selection of clinical study vendors (CRO, central labs, imaging, ePRO, etc.).
- Provide day-to-day oversight of CROs and third-party vendors (setup, logistics, documentation, and clinical supplies).
- Own trial-level clinical operations budget, invoices, and change orders.
- Work with Clinical Business Operations on budget forecast and monthly accruals.
- Collaborate with Site Relationship Manager to meet enrollment goals and timelines.
- Develop and maintain study timelines, enrollment dashboards, and status reports.
- Respond to RFIs from Regulatory Authorities, IRBs, and Ethics Committees with timely submissions.
- Contribute to clinical documentation (protocols, informed consents, study-level plans/manals, training materials).
- Participate in CRF development and EDC/IRT specification and UAT.
- May assist with new/updated clinical SOPs/processes.
- May train/mentor/manage junior team members.
- May participate in departmental initiatives.
Qualifications:
- B.A. or B.S. (preferably scientific).
- 7+ years pharmaceutical industry experience; 4+ years trial management experience for Phase II/III; multi-country global study experience required.
- Prior CRO management experience.
- Experience with clinical study budgets.
- Solid drug development process knowledge; ICH GCP and clinical trial process steps.
- Independent, detail-oriented problem-solving; risk-based decision making.
- Excellent written/verbal communication.
- Strong leadership and decision-making.
- Experience with key stakeholders (clinical development, regulatory, QA, supply chain).
- Comfortable in fast-paced start-up environment with evolving processes.
- Flexibility for non-traditional hours across time zones.
- Travel up to 25%.
Compensation/Benefits:
- Competitive compensation and benefits package; base salary range: $149,300 to $186,630; total rewards may include annual performance bonus, equity, and full range of benefits.
The Sr. CPM is the Global Project Lead for a Phase 3 Multiple Sclerosis study, responsible for day-to-day operational management of the trial and oversight of CROs and clinical vendors. Reports to the Senior Director, Clinical Project Management.
Key Responsibilities:
- Manage all operational aspects of a global clinical trial from start-up to close-out; identify and resolve operational issues to meet timelines, budget, milestones, and applicable SOPs, guidelines, and regulations.
- Partner with cross-functional clinical development teams to ensure proper execution.
- Chair internal Study Team Meetings.
- Participate in evaluation and selection of clinical study vendors (CRO, central labs, imaging, ePRO, etc.).
- Provide day-to-day oversight of CROs and third-party vendors (setup, logistics, documentation, and clinical supplies).
- Own trial-level clinical operations budget, invoices, and change orders.
- Work with Clinical Business Operations on budget forecast and monthly accruals.
- Collaborate with Site Relationship Manager to meet enrollment goals and timelines.
- Develop and maintain study timelines, enrollment dashboards, and status reports.
- Respond to RFIs from Regulatory Authorities, IRBs, and Ethics Committees with timely submissions.
- Contribute to clinical documentation (protocols, informed consents, study-level plans/manals, training materials).
- Participate in CRF development and EDC/IRT specification and UAT.
- May assist with new/updated clinical SOPs/processes.
- May train/mentor/manage junior team members.
- May participate in departmental initiatives.
Qualifications:
- B.A. or B.S. (preferably scientific).
- 7+ years pharmaceutical industry experience; 4+ years trial management experience for Phase II/III; multi-country global study experience required.
- Prior CRO management experience.
- Experience with clinical study budgets.
- Solid drug development process knowledge; ICH GCP and clinical trial process steps.
- Independent, detail-oriented problem-solving; risk-based decision making.
- Excellent written/verbal communication.
- Strong leadership and decision-making.
- Experience with key stakeholders (clinical development, regulatory, QA, supply chain).
- Comfortable in fast-paced start-up environment with evolving processes.
- Flexibility for non-traditional hours across time zones.
- Travel up to 25%.
Compensation/Benefits:
- Competitive compensation and benefits package; base salary range: $149,300 to $186,630; total rewards may include annual performance bonus, equity, and full range of benefits.