Senior Clinical Project Manager
Remote , MA 02459-3215 US
Title: Senior Clinical Project Manager
Hiring Organization: Connexion Systems & Engineering
- Duration: Temp to Perm
- Pay rate: $150-160k
- Job Location: Waltham, MA (Remote Possibilities)
- Job# 15171
Summary: The Senior Clinical Project Manager is responsible for the planning, implementation, execution, and management of one or more clinical research studies. She/he manages clinical outsourcing to CROs and other vendors such as labs, IRBs, etc. She/he may author, review, and approve various study-related documents and plans. She/he evaluates issues, interprets data, and suggests and implements solutions and mitigation as required. She/he is responsible for the financial management of a study/program and develops and oversees study timelines.
- Represents and leads the study team to design, develop, execute, and deliver the clinical study in accordance with the clinical development plan/strategy and timelines
- Authors/ reviews/ contributes to clinical study documents
- Reviews and approves study-related plans generated by Clinical CROs and vendors
- Provides input as the subject matter expert for the study during regulatory inspections
- Accountable for the timely clinical review and/or approval of Case Report Forms, User Acceptance Testing (UAT), and provides clinical input into corresponding completion guidelines
- Responsible for oversight of identification and selection of investigator sites
- Responsible for planning and conducting investigator’s meetings in cooperation with the respective departments
- Ensure the delivery of clinical trial supplies in collaboration with the clinical supply team
- Collaborates with the cross-functional team on selection and management of clinical vendors
- May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance
- Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans through regular investigator site / CRO / clinical vendor contact
- Requests and critically evaluates proposals and change orders from CROs and vendors
- Attend relevant symposia, conferences, and scientific meetings, as necessary
- May directly manage or line manage other clinical operations staff members
- Bachelor’s degree or nursing degree is required. Scientific/health care field preferred, but not required
- 5+ years’ experience working in clinical operations within a pharmaceutical/biotech company with a focus in oncology.
- Minimum of 3 years’ experience working as a Clinical Research Associate (CRA) and/or monitoring experience
- Global clinical trial experience and the ability to lead/manage more than one clinical trial
- Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines
- Strong knowledge of applicable computer and project management software packages
- Familiarity with financial budgeting and forecasting or reporting
- Strong interpersonal skill set to interact with investigators, vendors, and individuals at all levels of the organization
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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