US, PENNSYLVANIA , Fort Washington
Position Type : Full Time/Contract
Job Id : 20-16678
Job Description :APPLY NOW
US, PENNSYLVANIA , Fort Washington
The Senior Clinical Project Manager will use clinical and scientific knowledge as well as leadership and influencing skills to lead, plan, and manage clinical studies in support of the clinical development plan. As a senior clinical project manager, you will work across functionalteams to provide project Leadership and Delivery and Leadglobal clinical team to ensure quality, timelines and budget management. It is a role that requires direct liaise between many functions and the customer, acting as the accountable point for delivery and quality whilst maintaining financial control. This includes the financial performance of assigned projects and for all project deliverables for assigned projects and/or project regions and coordinating activities and deliverables of all project conduct partners and proactively identifies and manages issues.
Duties and Responsibilities:
- Serving as the primary project contact with the client, Leading and managing cross-functional project teams.
- Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements.
- Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
- Monitoring team performance against contract and client expectations and according to key performance metrics.
- Leading problem solving including management of risk and issue resolution. Lead creation of risk management plan for assigned studies and propose strategies to mitigate timeline and quality risks.
- Developing or reviewing study management plans.
- Managing team resource assignments and accountability.
- Ensuring compliance with study tools including clinical trial management system and document management system, training materials and standard processes, policies, and procedures. Track study progress with appropriate metrics for recruitment, payments, etc.
- Collaborating and communicating with a variety of colleagues and clients. Communicate study timeline expectations to internal and external study team members.
- Participate in review of project documents, e.g., CRFs (or EDC equivalent), ICFs, recruitment materials, clinical monitoring plans, operation manuals, SOPs, participate in review of protocols, IBs, and clinical sections of NDAs, sNDAs and INDs (including annual reports).
- Assists in the selection, qualification, and management of vendors to support clinical trial execution.
- Develop creative solutions for study recruitment challenges and lead implementation with study sites. Respond to study site questions and escalate internally as appropriate for resolution.
- Assists in pre-study site evaluations as well as new site initiations and trainings and in the development and management of site budgets, timelines, and metrics; ensures completion of study deliverables; provides status update reports.
- Oversee monitoring of study sites and Co-conduct site initiation visits and interim monitoring visits as necessary.
- Lead planning and implementation of investigator meetings.
- Reviews monitoring reports, site audit reports to ensure quality and resolution of site-related issues.
- Ensures tracking and review of protocol deviations and assesses impact on stu