Majority of studies are late phase - iii, iv, registry studies, etc.
Therapeutic area is Rare Disease.
Focus on close out activities and TMF compliance.
Work ethic/initiative
Sponsor side experience
Depth of site close out experience
Summary of Key Responsibilities:
This position will manage the administrative aspects of clinical trials at every stage of the
process (study documents, implementing and maintaining databases, coordinating payments and supplies to research units).
Study Documentation: Prepares / assembles study documentation and support the Clinical
Project Manager in ensuring the compliance of the clinical trial with internal SOPs and regulations.
TMF Management: Handles and maintains electronic/ paper TMF and electronic internal repository according to ICH/GCP guidelines and European standards. Responsible for periodic quality checks and general oversight of TMF as well as TMF reconciliation after study completion. Support the CTM in TMF audit and inspection readiness activities.
10% Clinical Trial Supplies: Collaborates with Clinical Project Manager, Clinical Supply Unit and QA in order to manage activities related to Clinical Supplies. Manages study related payment
procedures. Interacts with external providers during study conduct (CROs, monitors and,
occasionally, with investigators and Hospital personnel).
Budgeting/RFPs: Provides input for budget development and checks monthly costs invoiced to client based on planned study activities vs actual. Participate in the completion and review of the RFPs in collaboration with the Clinical Project Manager.
Organizes and/or participates Kick-off Meetings, Study Design Meetings, and phone-conferences
with the CROs for the continuous update on clinical studies. Ensure appropriate meeting minutes are prepared and filed in TMF.
Requirements:
4+ years of experience as a Clinical Trial Associate
Sponsor side work experience
Late stage study experience is required.
Study Closeout is required.
Experience with eTMF systems is required (Veeva being the most common).
Team player, shows initiative
Excellent at relationship building and accountability.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/
Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/
Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records."
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Other
Industries
Biotechnology Research
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