Job: Clinical Trial Manager, Locus Biosciences, Morrisville, NC
Locus Biosciences is seeking a Clinical Trial Manager with experience managing Phase 1-4 clinical studies from the protocol concept through the clinical study report. This position will be responsible for the on-time completion of study deliverables by providing oversight and management of CROs and other clinical service providers for assigned studies. This individual will work closely with company executives, cross-functional leadership, and external vendors across various strategic and operational initiatives to support overall clinical development activities.
Responsibilities will include:
Reports directly to the Vice President, Clinical Operations with responsibility to:
Plan and manage assigned clinical trials within the approved budget and timeline.
Participate in the development of clinical protocol concepts, summaries, protocols, and their amendments for assigned clinical trials.
Develop the operational strategy for assigned clinical studies, including the clinical vendor identification, country/site feasibility, and patient recruitment/retention strategy.
Lead the identification and selection of the CRO and other clinical service providers associated with assigned clinical trials.
Lead or participate in the negotiation of the CRO and other clinical service provider contracts and/or work orders, including any change orders.
Ensure that clinical studies are conducted in accordance with executed contracts.
Ensure that clinical studies are conducted in accordance with SOPs, GCPs, ICH guidelines, and all applicable regulations.
Provide oversight of CROs and other clinical service providers through:
Review and approval of study plans including, but not limited to, the regulatory plan, monitoring plan, patient recruitment/retention plan, communication plan, data management plan, statistical analysis plan, laboratory services plan, and clinical supplies plan.
Review and approval of the clinical site contract and budget templates, including any amendments.
Review and approval of the informed consent form, including any amendments.
Review and approval of the set-up of systems such as IRT and EDC.
Review and approve site regulatory packets and activations.
Review and approval of the statistical analysis plan.
Review and approval of the clinical study report.
Support with the negotiation of clinical site contracts and templates where necessary.
Participation in the development and presentation of investigator meetings and other study-related meetings.
Conduct site visits and contact sites regarding recruitment, site issues, etc.
Ongoing review of vendor KPIs/KQIs and address identified deficiencies.
Monitoring for safety-related issues, ensuring follow-up and support of necessary actions.
Review of TMF for accuracy and inspection readiness.
Other vendor oversight activities as identified in contracts and Locus SOPs.
Identify and contract drug packaging vendor, prepare packing and labelling campaign(s), and coordinate activities and timings in collaboration with Locus CMC team
Identify and contract central and specialty laboratories, prepare lab manuals, support development of protocols, review and approve clinical site guidance and reference charts, etc.
Review and approve invoices from vendors and sites ensuring compliance with contract and approved budget. Identify any budgetary impacts and proactively address corrective actions.
Set-up and manage Data Safety Monitoring Committees when needed.
Participate in the development and updates of key documents such as INDs, Investigator Brochures, Pharmacy Manuals, etc.
Prepare or update Clinical Development SOPs as needed.
Work collaboratively across Locus departments in overall clinical study planning, management, and close-out activities.
Act as the main Locus contact internally and externally for assigned clinical studies.
Other activities as assigned.
Candidate must possess:
A minimum of 5 years of Phase 1-4 clinical trial management experience in a pharmaceutical/biotech and/or CRO setting
Experience with managing global studies through CROs and/or other clinical service providers
Knowledge of ICH/GCP and other country-specific regulations and guidelines
Knowledge of the principles in planning, conducting, and monitoring global clinical trials
BS/BA in Life Sciences or similar discipline
Effective problem-solving ability and communications and interpersonal skills
Strong organizational and time-management skills with the ability to multi-task effectively
Ability to actively produce tangible work products that help deliver on key drug development milestones
Ability to travel, including international travel
Experience supporting IND and BLA submissions
Experience managing clinical studies in Infectious Disease
Ability to assist in budget and contract management
Hands-on experience with timeline/planning software (e.g. MS Project)
Job Type: Full-time
Job Location: Research Triangle Park, North Carolina
For immediate consideration, please email your resume or CV to: email@example.com
Direct applicants only. No agencies please.