Clinical Project Manager

AMER • Fishers, IN

1d

About The Position

The Clinical Project Manager (CPM) is responsible to support and oversee the day-to-day responsibilities of multiple early phase regional clinical trials from protocol conception, start-up through the clinical study report, including all aspects of project document development, budget, safety, and quality in an environment where problem solving, critical thinking, teamwork and flexibility are vital to success. The CPM will work closely with CROs and/or third-party vendors and closely collaborate with cross-functional internal and external stakeholders to ensure adherence to GCP, SOPs, and FDA/ICH guidelines and ultimate delivery of high-quality data within the defined timelines and approved budget. The CPM ensures completion of study deliverables and proactively identifies and resolves clinical project issues.

Requirements

• Bachelor’s degree in life sciences
• At least 2 years of relevant experience in Clinical Trial Project Management
• Strong understanding of all aspects of clinical trials; experience with early phase clinical trials (Phase 1 - 2), oncology and/or radiopharmaceutical experience preferred.
• Ability to deal with multiple priorities with aggressive timelines.
• Thorough knowledge of ICH GCP, drug development, clinical research industry practices and regulatory processes.
• Strong analytical, organizational, planning, decision making, negotiation, and conflict management skills.
• Ability to build and maintain successful professional relationships with internal cross-functional teams, vendors and investigational sites.
• Fluent in Microsoft Office products (Word, Excel, SharePoint, Teams, etc.) and proficiency using electronic platforms (CTMS, eTMF)
• Regional start-up experience (site feasibility, ethics & regulatory submissions)
• Demonstrated ability to pivot study strategy quickly and lead teams in the right direction working in a fast-paced environment.
• Experience in conflict resolution, clinical project management practice, risk management, and an understanding of project financials.

Responsibilities

• Support the planning and setup, maintenance and closeout phases of multiple concurrent clinical research studies
• Proactively managing all aspects of the trial process including vendor selection, site feasibility and selection, trial clinical timelines, clinical budgets, resources, and vendor relationships
• Provide day-to-day study management including, but not limited to oversight of CRO, study vendors and investigational sites in coordination with various cross-functional team members and study team.
• Monitoring all work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget.
• Support the drafting, review and updating of documents related to clinical development such as Clinical Trial Protocols, Informed Consent Forms, Investigator’s Brochure, Laboratory Manual, IMP Handling Manual, etc.
• Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs
• Identify and mitigate risks and apply strong problem-solving skills to ensure timely resolution of all study related issues
• Manage, facilitate and/or monitor the completion of interdisciplinary project tasks including site monitoring/audits, CRF and database development / revision, data collection, patient safety / AE management, document management, statistical analysis / final report writing, and study close out.
• Management of small or medium-sized projects or regional leadership of complex multi-center clinical research projects
• Oversee the study specific Trial Master File (TMF) and assist with periodic audit of the TMF
• Perform any other tasks/duties as assigned by management

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level