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Clinical Study Associate Manager

Boston, MA 02108

Posted: 06/12/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 607241 Is job remote?: No Country: United States

Job Description

Clinical Study Associate Manager

Job Summary:

Clinical Study Associate Manager supports the study team by taking responsibility for areas of clinical trial delivery. This role applies to internally sourced studies. The individual will work in tandem with the study team internally and externally with vendors in planning, initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and Standard Operating Procedures (SOPs).

Job Responsibilities:
  • Planning and running a clinical study in an assigned region(s) in alignment with the global study plans
  • Support and management of study close out, database cleaning, IP reconciliation, etc.
  • Contributing to risk assessment and helping to identify risk mitigation strategies
  • Supporting feasibility assessment to select relevant regions
  • Support of study specific documentation e.g. case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc
  • Reviewing site level informed consents and other patient-facing study start-up materials
  • Responsible for support and management in the setting up and maintenance of study systems such as Clinical Trial Management System (CTMS) and Trial Master File (TMF)
  • Contributing to investigator meeting preparation and execution
  • Engagement, contracting and supervision of required vendors for the study
  • Providing regular status reports to team members as requested by the CSL
  • Contributing to development and implementation of recruitment and retention strategies, and monitoring these accordingly 
  • Supporting data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites
  • Escalating data flow and/or quality issues, and any timeline or budget issues to the CSL
  • Participating in clinical project audit and inspection readiness throughout the study lifecycle, and assisting with CAPAs as required
  • Managing aspects of study close-out activities such as database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability
Qualifications:
  • Bachelor’s Degree
  • 5+ years’ industry related work experience with a CRO and or a Biotechnology or Pharmaceutical company ONLY
  • Candidates who have some vendor management experience, as well as experience in clinical trial operations including developing key study documents and excellent experience with the entire spectrum of a clinical trial.
  • Must be versed in early and late phase clinical trials including close out activities.
  • We also require someone who has technical proficiency in trial management systems, Microsoft applications and TMF, as well as familiarity with medical terms, and a knowledge of Good Clinical Practice and regulatory guidelines.
  • Some travel may be required.

 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Boston, MA

Ready to take your career to new heights? Explore our job opportunities in the vibrant Boston, Massachusetts area! Known for its rich history, world-class universities, and thriving tech and healthcare sectors, Boston offers a unique blend of opportunity and charm. Imagine working near iconic landmarks like the Freedom Trail, indulging in delicious clam chowder, catching a show at the Boston Opera House, or cheering on the beloved Red Sox at Fenway Park. With renowned art galleries, theaters, and the stunning Boston Common right at your doorstep, there’s no shortage of ways to enjoy work-life balance in this dynamic city. Discover your next career move in Boston today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.