Clinical Study Associate Manager

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. Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements. Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs. Apply tot his job