Senior Clinical Trial Manager

4 weeks ago

Boston, United States Third Rock Ventures Full time

As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition and a passion to create impactful neuromedicines, with fewer side effects, that allow patients and their families to live healthier and more fulfilling lives.

On a molecular scale, our deep understanding of the intricate relationships between receptors, their associated proteins, and their distributions in specific cell types and brain regions enables us to precisely direct medicines to the neural circuits underlying disease pathophysiology.

The Senior Clinical Trial Manager (or Associate Director, commensurate with experience) will be responsible for leadership and oversight of all clinical trial activities including vendor oversight and management, from study start-up through execution and close out of all clinical trials within the early phase team supporting Clinical Development within the R&D organization.

Responsibilities will include but not be limited to:

* Responsible and accountable for planning and execution of early phase clinical projects: oversight and directional alignment of timelines, budget, and key deliverables as well as contributing to overall early phase clinical strategy.
* Provide input into and oversee development of clinical plans, detailed study plans and clinical documents (synopses, protocols, ICF's, IB's and CSR's).
* Proactively manage and oversee Phase I Units, sites, associated CRO's and all study related vendors to ensure trial deliverables and performance goals are met and high level of operational excellence is maintained.
* Lead internal cross-functional early phase Clinical Study Team meetings and participate in external study related team meetings with vendors.
* Oversee clinical systems and technical integrations for databases, CTMS, eTMF, central reading, and other trial execution and/or data collection platforms.
* Set operational performance goals, key performance indicators and targets.
* Ensure all early phase trials are conducted according to relevant ICH/GCP guidelines and applicable local regulations.

Job Requirements:

* Bachelors Degree in life sciences
* Strong people and project management skills
* Minimum of 10-15 years of clinical operations experience in a pharmaceutical or biotech or CRO setting
* Trial execution experience from Ph1 through Ph3
* IND submission experience
* NDA submission experience a plus
* Excellent leadership skills and ability to lead, direct and support cross-functional teams
* Strong interpersonal, organizational, and multi-tasking skills
* Excellent knowledge and understanding of GCP/ICH and EU Guidelines for conducting clinical trials, and have inspection experience

Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

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