Albion Rye Associates are searching for an experienced Clinical Project Manager (CPM) to join an exciting Biotech based in the US. The ideal candidate will have pervious experience as a CRA from a CRO, Biotech or Pharmaceutical environment, and have a minimum of 3+ years experience in Clinical Project Management.
The CPM will be responsible for the on-time and on-budget delivery of the study/studies, and will be pivotal in the execution of each stage of the trial, from initial conception, Study Start-Up and Site Initiation, full management of the process, through to close-out and successful outcomes.
- Develop study plan outlining planning, execution, and closeout milestones.
- Develop a study management plan in conjunction with the VP of Clinical Operations, and outlining target KPIs, risk assessment, and contingency planning.
- Lead multidisciplinary Study Management Team.
- End-to-end management of clinical studies to ensure appropriate resourcing and timely and high-quality delivery by all functional areas. Ability to identify and organize resources and services needed to accomplish tasks, set objectives, plan for contingencies, and managing time effect.
- Develop and monitor study metrics to continuously assess study progress.
- In collaboration with the study management team, and Marketing, develop a robust recruitment and retention data-driven strategic plan including risk assessment and contingency planning, at the start of the study and monitored throughout its duration and to close-down.
Project Analysis and Management
- Identify critical project success factors for tracking, analysis and reporting including impact and probability of project risks.
- Monitor and track study status, timelines, and budget expenditures; identifies opportunities and recommend implementation plan for efficiency measures.
- Accountable for overall study budget, ensuring that all invoices are paid, issues are addressed, and revenues are booked in timely manner.
- Ensures timely data entry, query resolution and prompt resolution of data issues.
- Coordinate assignment of needed resources for study conduct and completion with functional area leaders; ensure appropriate staffing to accomplish project goals within budget.
- Identify out-of-scope work and reports the scope change process to leadership.
- Responsible for review of study budget, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate project team members.
- Manage clinical research coordinators and their activities on each study.
- Ensure that study activities (personal and those of the Clinical Research Coordinators) are properly tracked and entered into the company’s time tracking/project management/resource planning software tool in a timely manner.
- Accountable for development, oversight and delivery of team training for specific projects.
- Apply expertise in day-to-day clinical operations activities, collaborate with internal and external cross-functional team members to develop study documents and manuals, including protocols, ICFs, manuals, presentation decks, risk plans, etc.
- Determines needed project processes and trains study teams; maintains study team knowledge and application of project processes.
- Establish and communicate team performance expectations and guidelines.
- Mentor and assist in coaching/training Clinical Research Associates and Coordinators.
- Conduct performance reviews, calibration sessions and feedback discussions for clinical research coordinators. Perform competency assessments across his/her team and implements and monitors development plans with direct reports.
- Manage performance of external service providers as required.
- Participate in development and review of departmental Standard Operating Procedures (SOPs), guidelines, intradepartmental procedures, and other continuous process improvements programs, as assigned.
- Bachelor’s degree in a Health or Scientific field required (minimum). Advanced degree or equivalent clinical research experience preferred.
- 8+ years of pharmaceutical/biotech-sponsored clinical study management experience or equivalent applicable experience.
- Experience in Managing Oncology studies (Phase I-III).
- Previous experience as a Clinical Research Associate (CRA) Desirable
- Must currently live in the US and have right to work