Associate Clinical Trial Manager

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.

Responsibilities:

• Provide support to the Clinical Operations Lead (COL) managing components of early phase clinical trials with minimal direction and oversight, while ensuring execution to specified quality standards
• Responsible for coordination and tracking of study related contracts and budgets, PO generation and lite management activities
• Review and track vendor invoices against contracts with oversight of study COL
• Manages the coordination of clinical trial equipment and clinical supply orders, logistics, and the drug release/approval process.
• With support from COL, manages specific vendors as assigned. Ensures timely meetings, includes appropriate stakeholders, identifies risks and escalates where appropriate.
• May be delegated Clinical Study Team responsibilities such as scheduling meetings, distributing agendas, developing slides, taking minutes, and as appropriate, leading the meeting as back-up to the COL
• Maintains study level timelines in conjunction with the CRO and communicates updates and changes to the Clinical Study Team as required
• Proactively communicates study updates with key internal and external stakeholders with use of standardized reports, dashboards and templates and other mechanisms
• Adheres to ICH-GCP, applicable regulatory guidelines, and company processes and SOPs. Applies best practices in clinical operations methodologies and systems with particular emphasis on quality, time, SOPs, and expectations.
• Actively participates in or leads cross-functional initiatives including the development and updating of standardized clinical trial tools, processes, and SOPs
• May lead or participate in the selection, start-up, and management/oversight of clinical service providers/vendors (CRO, RTSM/IXRS, labs, etc.)
• Assist or lead in development and review of study oversight plans, quality plans, pharmacy manuals, clinical components of regulatory submissions, risk management and corrective action plans, and study documents such as protocol, Investigator Brochure, informed consent forms, study execution plans, CRFs, Clinical Study Reports, etc.
• Coordinate and track the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF's, monitoring visit reports, etc
• Coordinate and/or oversee the study training for study teams, investigational sites, and vendors in collaboration with CRO
• Leads the setup, maintenance/oversight, routine audits, and close out of the Trial Master File (TMF) ensuring that study documentation is in a continuous state of inspection readiness
• Works independently on tasks and knows when to involve/collaborate with others
• Relies on senior team members for guidance but may mentor/coach junior team members
• Continues development through relevant/ongoing trainings, courses, and/or conferences.
• May oversee biological sample kit development, shipping/collection, tracking, reconciliation, and analysis as required

Qualifications:

• Bachelor's degree in life sciences or healthcare related field
• 6 years' experience in a clinical research related position
• Strong computer skills including knowledge of Excel, Word, PowerPoint and Outlook
• Solid understanding of the responsibilities and needs of other functions in a clinical trial
• Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
• Ability to multitask and flex across projects as priorities and deadlines shift
• Ability to maintain confidentiality of proprietary information
• A team player that takes initiative

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.

CCPA disclosure notice can be found here.