Planet Pharma · 1 day ago
Clinical Study Associate Manager
Massachusetts, United States
Full-time
Onsite
Senior Level
5+ years expPlanet Pharma is a company focused on clinical trials and research, and they are seeking a Clinical Study Associate Manager to support the study team in delivering clinical trial projects. The role involves planning, managing, and closing out clinical studies while ensuring compliance with regulatory standards and collaborating with vendors and internal teams.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
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
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
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