Sr. Clinical Trial Associate - Planet Pharma : Job Details

Job Description Sr. CTA You will be responsible for providing support to both the Clinical Operations study team members and to the cross functional execution team(s). Daily activities will focus on ensuring that the clinical trials remain on track and are consistent with related SOPs and ICH/GCP/regulatory guidelines. Ideally the CTA will have experience with and an understanding of clinical trial conduct including study start-up and conduct processes, clinical document review and tracking, vendor access and administration support, and finally utilization of an electronic Trial Master File (eTMF) and associated document management procedures. Job Responsibilities:

• Provide support to the clinical study team with many of the tasks involved with conduct of clinical studies in compliance with Company processes.
• Liaise with contract organizations and other vendors to ensure clinical study deliverables are met (i.e., contribute to documentation, processes, and set-up activities to facilitate efficient working and effective partnerships with external groups).
• Draft agendas, maintain meeting minutes, create materials, liaise with meeting planners, and coordinate logistics for internal or external meetings.
• Track and manage inventories of clinical study supplies
• Assist with study metrics and tracking of participant visits.
• Complete all study level submissions to central Institutional Review Boards (IRBs).
• Complete quarterly debarment checks for all active investigators.
• Contribute to the maintenance of existing eTMFs (i.e., collect documents from sites, manage and update expected document lists) and ensure inspection readiness of the eTMF through ongoing TMF completeness checks.
• Communicate with study investigators to provide updated study documents, weekly metrics, SUSARs and/or study status updates.

Minimum Qualifications:

• A Bachelor's degree strongly desired
• A minimum of 2-3 years industry experience working in the Pharmaceutical, Biotechnology or other related industry is required.

Preferred Qualifications:

• Strong attention to detail is a must.
• Extensive Veeva eTMF experience is a must.
• Able to work in a fast-paced environment with focus on quality.
• Good communication skills both oral and written are a must.
• Good computer skills are required.
• Working knowledge of MS Word, Excel, and PowerPoint is required.
• Excellent organizational skills are required.
• Must have an ability to multi-task.
• Oncology experience is preferred.

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.