Title: Senior Clinical Trial Manager
Company: Pharma Company
Location: Pittsburgh, PA
Type: Permanent Role
Notes: No Corp to Corp | Relocation Assistance Provided | Possible Remote Option
The Sr. Clinical Trial Manager will serve as an operational point person in the ongoing clinical trials and will be the lead of the upcoming study. The Sr. CTM oversees the daily operations of Clinical Trials. The Sr. CTM will work closely with internal functional team members, CROs/Vendors, collaborators, and participating sites to ensure that clinical studies are conducted in a timely manner to achieve study goals within defined budgets.
- Responsible for managing CROs/vendors for assigned trials ensuring adherence to defined scope of work and budget
- Identify issues and implement solutions to ensure timelines are maintained
- Develop and maintain tracking tools for clinical trials including study and monitoring visits, sample tracking, data entry and action item progress
- Assist with the drafting of protocols, informed consent forms, study operations guidelines and other study plans
- Develop trial specific training tools for site utilization
- Oversee maintenance of the eTMF
- Monitor and/or co-monitor clinical trial sites
- Plan and coordinate advisory boards, investigator meetings and CRA trainings
- Work collaboratively with supply chain to ensure seamless collection/manufacture
- Develop project-specific procedures and processes
- Recommend and follow up on corrective actions
- The candidate must maintain a high standard of professionalism, and confidentiality in this role and must be able to problem solve, communicate effectively, and trouble-shoot creatively
- BS or MS Degree in Health Sciences or related fields.
- 5 or more years in a Clinical Operations Management role
- Global trial management experience
- Prior Clinical Monitoring and/or CROexperience
- Laboratory experience is a plus
- Must be willing to travel domestically and internationally up to 15-20%
- Knowledge of industry standards as applied to ICH guidelines, GCPs and the CFR
- Excellent communication, writing and presentation skills
- Proficiency in study monitoring activities
- Proven Project Management Experience
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