Clinical Study Associate Manager

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.