General Job Description/Team Overview:
The Clinical Project Manager (CPM) oversees all trial activities from start-up to delivery of the final study report. This individual is responsible for the quality of all work done on the trial by establishing quality control procedures and must ensure adherence to all SOPs. The CPM serves as the leader and coordinator to execute Phase 1 oncology clinical trials while providing the groundwork for the upcoming Phase 2 trials. Responsibilities include creating an integrated clinical development plan aligned with the investigational product strategy to include scope, budget, timeline, and risk assessment. This position leads the clinical team’s identification and selection of CROs, KOLs, and investigation sites and manages the CRO and all CRAs. The CPM leads and has expertise in implementing, applying, and integrating clinical project processes and promoting open and efficient communication among and between various members and stakeholders. The CPM also oversees and administers the budgets and schedules the external audits. It is an excellent opportunity for a reliable, proactive individual who thrives in a dynamic biotech environment. The level will be determined based upon the candidate’s education, skills, and/or related experience.
Primary Duties and Responsibilities (include but are not limited to):
- Serves as the leader and coordinator for the execution and management of Phase 1 and Phase 2 clinical trials in oncology.
- Leads the team’s identification and selection of CROs, KOLs, and investigational sites.
- manages the CROs in the initiation, management, and completion of clinical studies per ICH guidelines, GCP, and company SOPs.
- Provides clinical input and manages the study team’s development of the key study documents, including protocols, ICFs, IBs, SRMs.
- Leads the completion of clinical sections for the regulatory filings, including INDs, amendments, annual reports, etc.
- Manages and reports study timelines, status updates, and alerts project team of potential delays.
- Provides clinical input into cross-functional activities, including assisting with project flow and input on strategic decisions in manufacturing.
- Manages the overall quality of the study data.
- Leads problem solving and resolution efforts to include management of risk, contingencies, and issues
- Provides specific training and education for internal and external project team members as needed.
- Meets objectives of the annual budgetary plan.
- Ensures project deadlines and performance standards are met.
- Operates both independently and as a team member depending on current company priorities.
- Exhibits a professional manner in dealing with others, working to maintain constructive working relationships.
- Supports the mission and strategic plan of the Company.
- Requires international traveling.
- Performs other duties as assigned.
Required Qualifications:
- Bachelor’s or Master’s degree preferably in health/medical related or life sciences area.
- At least 3 years of directly related experience in clinical trial management in a pharmaceutical, biotechnology, or academic environment with emphasis on Phase 1 / 2 clinical trials, particularly in oncology.
- Project Management certification a plus.
- Global trial experience.
- Therapeutic experience in oncology.
- Must possess a strong understanding of the clinical drug development, GCP, and the regulatory requirements for clinical trials.
- Must have a thorough understanding of clinical trial design, eCRF design, project management, and data handling.
- Must have experience in managing and working with CROs.
- Effective leadership skills, strong communication competency, and proven ability to foster team productivity and cohesiveness.
- Able to anticipate change and show flexibility.
- Proficient in computer skills, including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.
- Excellent organization skills with attention to detail and accurate record keeping.
- General knowledge of Federal and State regulatory requirements in a GxP environment.
- High degree of discretion dealing with confidential information.
- Ability and willingness to work flexible hours when needed.
- Demonstrated ability to work independently and in a team environment.
- Excellent written, verbal, and interpersonal communication skills.
- Eligible to work in the U.S.
Job Type: Full-time