Clinical Project Manager (100% Remote) Jobs in Actalent Boston, MA

Website Actalent

This Jobsfunter Listing is about Actalent in Boston, MA 2022

About the job

  • Accountabilities:*
  • Provide operational expertise and strategic input for assigned clinical trials.
  • Provide expertise and operational input into protocol synopsis, final protocol and other study related documents.
  • Challenges study team to ensure operational feasibility, inclusive of patient and site burden.
  • Validate budget and ensure impacts are adequately addressed.
  • Participate in country and site feasibility/selection process, with a focus on providing country insights, corporate agreement, and therapeutic expertise to ensure understanding between study execution plan and program strategy.
  • Challenge study team to ensure timelines meet the needs of the clinical development plan.
  • Ensure vendors are onboarded.
  • Provide guidance to strategic partners/CRO to ensure study issues are addressed and resolved.
  • Oversee study budget planning and management, and accountable for external spend related to study execution.
  • Oversee strategic partners/CRO/vendor selection, budget and contract negotiation, and proper guidance of performance for all activities assigned to a strategic partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.
  • Approval of essential monitoring documents/plans, periodic review of outputs and actions related to monitoring.
  • Review and endorsement of relevant study plans, as applicable.
  • Study team meeting management and attendance; regular review of meeting agendas and minutes.
  • Review outcomes/actions related to protocol deviations review; primary purpose of review is to help identify trends across sites or the study.
  • Documented review and monitoring of risks and decisions at the study level and implementation of mitigation strategies.
  • In partnership with data management, review and pressure test all database timelines and plans; ensure linkage between the strategy (i.e., filingegistration, data generation) with the tactical plan for database lock and CSR.
  • Ensure studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and attending the inspections.
  • Help with onboarding and mentoring of new dept members
  • Education & Experience:* Bachelor’s Degree (Life Sciences) 4-6 years’ experience in pharmaceutical industry or clinical research organization, including 2+ years clinical study management.

Experience must include Phase 2 and 3 studies (globally recruited).

Experience in more than one therapeutic area is advantageous. Pediatric experience is a plus.

Knowledge in global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP. Awareness of local country requirements. Excellence in project management and communication.

  • Additional Skills & Qualifications:* 3+ years clinical trial experience Experience managing vendors Ideally experience with Rare Disease, Cardiac or Muscular Dystrophy.

All Oncology is not ideal.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Company: Actalent

Vacancy Type: Full-time · Associate 

Job Location: Boston, MA

Application Deadline: N/A

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