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Senior Clinical Project Manager

Remote , MA

Posted: 12/21/2022 Industry: Scientific and Life Sciences Job Number: 15171

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

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.

Responsibilities:
  • 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

Qualifications:
  • 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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