Global Clinical Project Manager
Global Clinical Project Manager - Sponsor Dedicated
The CPM is responsible for execution of trial/program project management deliverables related to budgets and timelines. Evolution of CTOL and Program Coordinator. This position will primarily support the Global Program Leaders (GPLs) in management of a Clinical Team to meet the agreed upon deliverables as outlined in the Compound Development Plan (CDP). Services include understanding the drug development process to deliver a clinical program according to quality, timelines,andbudgetinclosepartnershipwiththeGPL,aswellaswiththe
Clinicalleaderandthe Project Management Lead (PML) responsible at the Clinical Development Team (CDT) level. Services include managing external partners and non-vendor relationships, managing stage gate activities for the TA governance(suchaswritingmemosandfacilitatingmeetings),liaisewithresponsibleforfunctionsclinical suppliesneededfortheprogram,addressing
Urgent Safety Measuresfortheteam ,andprovidingsupport for financial and timeline planning.
- Ensures trial/program efficiency; planning, governance, budget, timelines, forecasting
- Accountable for the process of creating and managing an integrated study schedule in MS Project, as well as overseeing the processes for scope management, resource management, and risk management
- Partner with the Global Program Leader, Clinical Leader, and Project Management Lead to ensure the clinical program is delivered according to the Compound Development Plan (CDP)
- Manage the trial-level budget and perform financial analysis to determine level of impact of changes to trial-level budget
- Develop and communicate cross-functional baselines of plans, including timelines, FTE, and OOP
- Conduct proactive change of scope analyses, communicating findings to mitigate risks to the team and key stakeholders
- Developing scenarios for budget and FTE forecasting in PLW, and for timeline in MSP
- Ensure clinical supply planning needs for the program are communicated and tracked
- Prepare materials and support stage-gate governance activities for the Therapeutic Area
- Support governance structures with co-development-development partners or other external partners as directed by the GPL
- Matrixed
Collaboration:
Operates within a network of relationships, collaborating across functions and geographies. - Regular Communication:
Frequent 1:1s, small group sessions, and offline updates (emails, Teams) with stakeholders. - Focus on planning, tracking & analysis Responsible for PM activities (update MSP, track program/trial-level budget and timeline).
- A minimum of a bachelor’s Degree or equivalent work experience is required, post-Graduate degree in Project Management or business is preferred
- Professional Project Management certification is preferred
- A minimum of 5 years direct pharma experience is required and in clinical drug development, clinical operations, clinical R&D experience preferred.
- A minimum of 3 or more years’ experience in Global Project Management is preferred.
- Proficient in MS Project or similar software application in managing projects in required
- Prior experience leading a cross-functional global teams is required
- Demonstrated ability to resolve conflict and influence teams without direct authority
- Successful experience in planning and management of governance bodies is preferred
- Ability to adjust working hours to accommodate US time zones
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