Senior Clinical Trial Associate
Centessa Pharmaceuticals
Job Overview
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Job Description
About Centessa Pharmaceuticals
Centessa Pharmaceuticals plc (Nasdaq: CNTA) operates with a unique, deconstructed R&D model. We prioritize data-driven decision making, led by subject matter experts, to advance a portfolio of high-conviction programs with strong biological validation. Our asset-centric approach, which minimizes centralized infrastructure and hierarchy, focuses exclusively on data-driven capital allocation. This model allows our teams to expeditiously interrogate key scientific hypotheses, aiming for improved success rates with greater speed and modest costs.
The Role: Senior Clinical Trial Associate
As a Senior Clinical Trial Associate, you will be integral to supporting the planning and execution of clinical studies across one or more clinical trials. Working closely with the Clinical Trial Manager (CTM), you will ensure that all activities, from site start-up through close-out, adhere to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory guidelines.
Key Responsibilities
- Assist and provide comprehensive support to the CTM and study team in the day-to-day operational management of assigned clinical trials.
- Support the CTM in the coordination, preparation, and documentation of internal and external meetings (e.g., Kick-Off Meetings, Investigator Meetings, vendor management meetings) by managing agendas, minutes, presentation materials, logistics, and travel arrangements.
- Take responsibility for organizing meeting logistics, agendas, and minutes for the clinical study team, ensuring adherence to established standards.
- Assist with financial tracking including purchase orders, invoices, site budgets, investigator payments, and Clinical Trial Agreements (CTAs).
- Contribute to tracking key site metrics and milestones such as Site Initiation Visits, site activation, subject recruitment and enrollment, critical study dosing days, assessments, scheduled Monitoring Visits, and Close-Out Visits.
- Maintain study-level tracking tools for team assignments and training, recruitment materials, compliance tools, laboratory kits, samples, study supplies, and vendor portal access.
- Support the CTM in vendor oversight, including the review of invoices.
- Contribute to the review of critical clinical documentation such as Informed Consent Forms (ICF), Study Reference Binders, Study Management Plans, Monitoring Plans, and study protocols.
- Manage and maintain the study team SharePoint environment.
- Assist in clinical site oversight, data entry timeliness, review of monitoring trip reports, and tracking the resolution of all action items.
- Support TMF management to ensure it is up-to-date and all essential documents are appropriately filed.
- Assist the CTM and study team in the review and cleaning of study data in preparation for database lock.
Qualifications
- B.A. or B.S. degree required.
- 4+ years of experience within a biotech or pharmaceutical organization, with at least 2 years specifically in clinical operations.
- Experience working with clinical sites, principal investigators, clinical operations staff, and CROs is a significant plus.
- Demonstrated knowledge and training in Good Clinical Practice (GCP) for clinical research studies.
- Proficiency with Microsoft Office software, particularly Outlook, Word, and Excel.
- Independently motivated, detail-oriented, and possesses strong problem-solving abilities.
- Excellent written and verbal communication skills.
- Flexible and adaptable to new situations as business demands evolve.
- Ability to work effectively from a virtual home office setting.
- Flexibility to work non-traditional hours when required, given international operations across time zones.
- Occasional travel may be necessary for investigator meetings, site visits, and/or professional conferences, with the amount being study-specific.
Compensation and Employment Details
The hourly rate for this contract position ranges from $65.00 to $75.00. Individual compensation will be determined based on qualifications, skills, relevant experience, and job knowledge. This is a contract role, and as such, is not eligible for company employee benefits including health insurance, retirement plans, or paid time off. Individuals will be employed by and receive compensation through Centessa's designated employer of record.
Work Location
This is a remote position based in the US.
Key skills/competency
- Clinical Trial Management
- Clinical Operations
- Good Clinical Practice (GCP)
- Trial Master File (TMF)
- Vendor Management
- Clinical Documentation
- Study Coordination
- Data Management
- Microsoft Office Suite
- Regulatory Compliance
How to Get Hired at Centessa Pharmaceuticals
- Research Centessa's culture: Study their asset-centric model, values, recent news, and employee testimonials on LinkedIn and Glassdoor.
- Tailor your resume for clinical operations: Highlight 4+ years of clinical trial experience, GCP knowledge, and proficiency in TMF and vendor management.
- Craft a compelling cover letter: Articulate your passion for clinical research, your ability to work remotely, and your precise fit for the Senior Clinical Trial Associate role.
- Prepare for behavioral questions: Showcase problem-solving, attention to detail, communication skills, and adaptability relevant to clinical study coordination.
- Demonstrate technical proficiency: Be ready to discuss your experience with Microsoft Office Suite, specifically Excel, and your understanding of clinical documentation processes.
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