Clinical Project Manager - Waltham,MA
Clinical Project Manager:
The Global Clinical Project Manager (CPM) in the oncology therapeutic area provides project management and leadership skills to global, cross-functional, cross-divisional teams in the successful delivery of early to late-phase complex, (i.e. multi-regions/indications and/or alliance partners) major development or life cycle management activities (including established/marketed products).
Responsibilities include strategic direction and translating the cross-divisional, integrated GPT product/program strategy into an efficiently executable plan; predicting and planning solutions to achieve successful operational execution; driving the team to achieve clarity on issues and focus on effective contingencies; interfacing with management and influencing decision-making, monitoring slippage and developing strategies to get back on plan and navigating through the internal governance for projects.
- Develop an oversight plan; plan will describe our oversight of the study execution with vendors, CRO and sites
- Develop a study level timeline and budget with internal leadership and CRO:
- Including key milestone deliverables with CRO, vendors as well as site enrollment
- Work with CRO to provide monthly metrics report to track against timelines (i.e. study dashboard report)
- Management of the study level budget and tracking against budget with all parties
- Review, provide input and guide completion of CRO study related plans (i.e. communication plan, monitoring plan, reg submission plans, training plans, blinding plans, risk mitigation plans, study close out plans, etc)
- Work with study team and CRO to provide regulatory submission strategy and plan including detailed submission document information; provide review and oversight of ICF template as well as site level ICF review
- Work with the study team and vendors to develop training for sites; to include slide presentations, test cases and retraining as needed; track and ensure adherence to training plan
- Ability to create a close out plan and ensure CRO, vendors and sites are aligned with deliverables and expectation
- In partnership with other functional areas, participate and provide feedback to other plans (data management, IWRS, medical monitoring/safety management plan, etc)
- In partnership with data management, create an internal data and protocol deviations review plan; ensure feedback and follow up to CRO with any concerns
- Participate and review quality plans and audits for the study and provide oversight of CAPA resolution with the CRO, vendors and sites as needed
- Co-manage vendors with CRO and ensure data quality
- Review and track monitoring report issues, GCP compliance concerns and monitor performance; oversight of timely issue resolution at sites; Perform and/or coordinate sponsor oversight visits at the clinical sites to ensure quality of monitoring and sites adherence to GCP
- Oversight of the TMF for the trial and responsible for oversight of CRO
If you or a Clinical Project Manager you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.
Sthree US is acting as an Employment Business in relation to this vacancy.