Actalent Clinical Trial Manager (REMOTE) in Boston, Massachusetts
A leading Biopharmaceutical company located in Boston, MA is seeking a Clinical Trial Manager with 3+ years of Clinical Trial Management to join their team! See below details of the role.
Customize/update any study-specific plans and process flows for multiple clinical vendors, as appropriate e.g., TMF Plan, site training plan, site monitoring plan, cross functional data review plan, IP release plan etc.
Ensure quality of the trial master file through content (QC) review of document packages submitted for entry into the TMF and liaise with project teams to resolve any issues identified with the documents submitted.
Assist CPL by tracking compliance to all study level plans and escalating any variances.
Serve as system expert and point of contact for business technologies used during the study (e.g., EDC, Investigator Portal, TMF).
Ensure CRA compliance with the study parameters via review of monitoring visit reports.
Track escalation and closure of action items noted in the monitoring visit reports.
Ensure registration of a protocol in ClinTrials.gov/EUdract and monitor its update throughout a study’s life cycle for compliance with the regulations and SOP.
Act as central point of contact for vendor providing this service.
Assist CPL with Interactions with CRO and site staff to adhere to study budgets.
Requests accruals, and performs contract and invoice review.
Participate in operation meetings with CRO, and cross-functional team members; document escalations and actions.
Coordinate study team training in the investigator portal; monitor site/CRA user access and track compliance during the study.
Coordinate with CPL and cross-functional team to assemble study documents as appendices for CSR at study close-out.
Upon site closure, prepares subject files, inventories documents, reconciles document discrepancies, and organizes study files for electronic archive and off-site storage.
SME for initiatives in conjunction with the CoE, as required to ensure consistent implementation of best practices across all studies and within a franchise.
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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