Clinical Trial Manager
About The Position
The Clinical Trial Manager owns clinical delivery and operational oversight of clinical research trials. Working with project managers and functional leads, the role delivers clinical and start-up activities within budget and contract while ensuring quality, compliance, and country-specific commitments. The position generally works under the direction of a (Senior) Clinical Trial Manager, but may work independently on lower-complexity studies. The role oversees start-up and clinical responsibilities from site identification through database lock, including management of scope, timelines, milestones, budgets, risks, resources, site activation and recruitment, regulatory submissions, trial supplies, monitoring, patient safety, vendors, and trial documentation. It also supports client communication, team collaboration, new-business preparation, and team feedback. Work is remote-based, with possible office presence depending on location and travel of up to 20%.
Requirements
- University or college degree, preferably in life sciences, or certification in a related allied health profession from an appropriately accredited institution; relevant equivalent experience may be considered in lieu of education.
- Fluency in written and spoken English.
- Four or more years of relevant clinical research experience in a pharmaceutical, CRO, or health care setting will be considered.
- Previous SSU and Clinical Trial Lead experience.
- Comprehensive knowledge of GCP, ICH, and regulatory guidelines.
- Proficiency in Microsoft Office and familiarity with EDC, CTMS, eTMF, and vendor platforms such as Veeva Vault and Medidata.
- Ability to lead effectively in remote and global environments.
- Strong communication, planning, and organizational abilities.
- Proven team-motivation skills.
- Ability to balance concurrent tasks in time-sensitive environments.
- Financial awareness and experience using tracking systems or tools.
- Independent problem-solving and risk-management mindset.
- Professional client interaction and presentation skills, and ability to work independently and collaboratively.
Nice To Haves
- Master’s or other advanced degree.
- PMP certification or equivalent.
Responsibilities
- Oversee start-up and clinical responsibilities from site identification through database lock, proactively managing project scope, timelines, milestones, and budget.
- Ensure project plans address identified risks and comply with professional standards, SOPs, client requirements, and regulatory requirements.
- Identify and address project, financial, and quality risks using risk-management strategies and applicable tracking systems.
- Manage financial aspects of clinical and start-up activities, including revenue forecasting, contracted scope, and scope modifications.
- Ensure the project team understands and tracks Key Project Indicators and client-specific metrics.
- Plan start-up and clinical resources and provide accurate projections to resourcing teams.
- Develop and implement site activation and recruitment strategies with project teams.
- Lead and oversee site identification and site selection.
- Oversee Informed Consent Form development and translations.
- Oversee creation and collection of essential documents, including insurance.
- Oversee development, negotiation, and execution of Clinical Trial Agreements, including site budgets.
- Lead regulatory and ethics committee submissions, approvals, and tracking.
- Ensure clinical and ancillary supplies and applicable import/export logistics and supply destruction processes are in place.
- Manage operational support for subject recruitment and retention, patient safety, vendor performance, and monitoring visit strategy.
- Plan monitoring activities to protect data integrity, patient safety, and endpoints.
- Ensure inspection readiness through quality oversight of the TMF, monitoring reports, protocol deviations, and issue management.
- Oversee and approve site payments, including payment reconciliation.
- Promote effective communication and collaboration with clients and cross-functional project teams in a global, multicultural environment.
- Lead client-facing calls to communicate project status and demonstrate operational control of start-up and clinical deliverables.
- Support new business through active participation in pre-award preparation as required.
- Provide feedback on team members to their respective line managers as needed.
- Perform other duties as needed or assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
