Actalent Clinical Project Manager (REMOTE) in Boston, Massachusetts
A leading Biopharmaceutical company located in Boston, MA is seeking a FULLY REMOTE Clinical Project Manager with 3+ years of Clinical Trial Management to join their team! See below details of the role.
Protocol review to ensure seamless integration between clinical objectives and study performance.
· Work directly with internal Clinical Operations Lead and internal and external medical experts to optimize and implement clinical studies.
· Participate in CRO and study vendor review, selection, and negotiation for each study.
· Lead interaction and maintains strong oversight of CROs in all aspects of study implementation and any study changes.
· Participate in review of all supporting documents for a clinical study – Protocols, Informed Consent Forms, CRFs, Clinical Study Reports, etc.
· Joint responsibility with Clinical Operations leads for monitoring the implementation and progress of a clinical study.
· Support the development and implementation of standard operating procedures and common work practices within the team.
· Work closely with the cross-functional study team including the Clinical Operations team and is responsible for coordination, tracking, and management
of logistics in support of clinical trials.
· Track study status, enrollment, regulatory documentation, and site start‐up status for assigned clinical projects including review and approval of regulatory package for release of clinical supply.
· Review clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, country/site-specific Informed Consent Forms, timelines, etc.
· Develop and maintains relationships through regular interactions with CROs, vendors, investigators, monitors and other external partners while providing information and resolution for specific study requests and issues.
· Provide management with routine updates regarding the status of ongoing studies.
· Able to identify potential study risks/issues and act proactively with resolution.
· Ensure operational activities across studies and indications are managed using consistency where possible.
· Maintain strong oversight of CRO and study vendors in all aspects of study implementation, such as ensuring documentation is appropriate, resourcing needs are met and issue resolution is accurate.
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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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