Actalent Clinical Trial Manager- Level I in Radnor, Pennsylvania
Manages the operational aspects of assigned clinical trial(s), including liaising with investigational sites, develops study specific tools and documents and provides overall direction for the clinical sites and study team members. Ensures that clinical trials are conducted according to the study protocol and in compliance with all applicable SOPs and regulatory guidelines. Possesses the ability to work efficiently in a fast-paced virtual environment. Work as a team, will be managing 1-2 Clinical studies in different life cycles/stages. Also assist other CTMs on assigned study(s). Primary Responsibilities and Duties: • Working with Full Service CROs with day to day activities. Vendor and CRO management support. • Assists in the review and preparation of clinical study plans & documents, including study protocols, amendments, model ICFs, laboratory manuals, CRF completion guidelines, study specific instructions, etc. • Oversee training tasks including but not limited to track training, deploy new team member training, identify training documentation gaps and close gaps with proper documentation • Assists with TMF QC, preparing CRO teams to conduct the QC • Routinely reviews study data and progress of EDC entry; works with data management and clinical sites to resolve data discrepancies. • Participates in weekly conference calls with sponsor and CRO. • Provides timely and accurate information to Management for project level tracking. • Participates in evaluating investigational drug (IP) supply requirements and manages the logistical aspects of distributing supplies to the investigational sites. • Identifies program/clinical trial risks; proactively suggests and implements mitigation strategies. • Oversee the management of vendors to get deliverables delivered on-time and on-budget. • Performs job duties with minimal supervision and has a sound critical thinking and problem-solving skills.
Clinical Project Manager, Trial Manager, Vendor Management, Project management, CRO Management, TMF QC, Tracking Clinical Study Data, CNS, global, CRA, Monitor, Oncology, In-patient, IV study
Top Skills Details:
Clinical Project Manager, Trial Manager, Vendor Management,Project management,CRO Management,TMF QC,Tracking Clinical Study Data
Additional Skills & Qualifications:
Qualifications/Experience: Bachelor’s degree required 2+ years of Trial Management Experience TA experience within IV studies, in-Patient, or Oncology studies CRO Management Experience QC experience Experience reviewing and preparing study plans and documents Strong ability to work with different IT systems and working with Excel and diverse systems (CTMS, etc) is required.
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