Clinical Project Manager, Temp to Perm
About The Position
The Clinical Project Manager, Temp to Perm, supports Protara Therapeutics’ Clinical Operations Team across ongoing programs. The role provides operational support for clinical trials, including coordination with internal and external stakeholders, oversight of CRO deliverables, and support for trial sites, vendors, study documents, budgets, enrollment, and eTMF management. The position also helps ensure that studies remain on schedule, compliant, and prepared for inspection, and identifies potential study risks and recommends solutions. The role works cross-functionally with clinical, regulatory, safety, and other teams; interacts with CROs, trial sites, investigators, study coordinators, pharmacists, CTMs, and CRAs; and prepares metrics and updates for senior management. It may include mentoring junior staff and travel to clinical research sites, vendors, and Protara’s New York City office as needed. The position is described as temp to perm, with an hourly rate of $68–$78 based on experience and qualifications.
Requirements
- Bachelor’s degree in clinical research, life science, or a related field.
- At least 5 years of relevant clinical trial management experience in the pharmaceutical or biotech industry.
- Knowledge of ICH, GCP, and CFR guidelines.
- Prior experience with different EDC platforms.
- Proficiency in the MS Office Suite.
- Knowledge of the clinical trial monitoring process.
- Strong ability to prioritize tasks with keen attention to detail.
- Strong organizational, analytical, problem-solving, and communication skills.
- Dependable self-starter able to work independently, prioritize tasks, and meet deadlines.
- Ability to thrive in a small, fast-paced biotech environment.
- Strong interpersonal skills and ability to interact effectively with all levels of internal and external management.
- Willingness to travel to clinical trial sites, vendors as applicable, and the New York City office as needed.
Nice To Haves
- Knowledge of Smartsheets.
Responsibilities
- Serve as the secondary clinical operations contact for one or more clinical trials.
- Coordinate with other functions to provide study-specific information for regulatory submissions and safety reporting.
- Work with cross-functional team members during study conduct.
- Review bid-defense proposals; assist with CRO selection, letters of intent, statements of work, budgets, and timeline development.
- Support vendor selection, onboarding, and management throughout the study lifecycle.
- Manage study-specific eTMF activities and support inspection readiness.
- Assist with clinical trial financial management, including review of CRO invoices, work-completed workbooks, site budgets, and site invoices.
- Interact with CROs, clinical trial sites, investigators, study coordinators, pharmacists, and Protara personnel.
- Serve as a resource for internal and external teams and investigational sites.
- Remotely monitor EDC data on a predetermined basis for expected interim data cuts.
- Review clinical protocols, amendments, informed consents, CRF and source-document designs, monitoring plans, site instruction manuals, protocol-specific training documentation, oversight plans, and other project documents as applicable.
- Assist with identifying, selecting, activating, and supporting participation of global clinical trial sites.
- Assist in reviewing pre-study site, site initiation, interim, and close-out visit reports within specified time frames as applicable.
- Oversee tracking of study recruitment and enrollment, trial-specific reports, and documents needed for trial completion.
- Perform internal oversight of CTMs and CRAs conducting site monitoring visits.
- Serve as the primary point of contact for internal CTMs and CRAs.
- Proactively identify and manage study issues and risks, and recommend or implement solutions with internal and external stakeholders.
- Prepare metrics and updates for senior management.
- Mentor junior staff and perform additional duties or functions as required.
- Contribute to wider organizational goals and activities as assigned.
- Travel to clinical research sites to perform CRO clinical monitoring oversight as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
