Job details
Job type contract
Full job description
The clinical trial manager will be responsible for managing clinical trial sites from study start-up throughout the course of the clinical trials until site close outThey will work to oversee that all aspects of the conduct of the trial sites and or across their assigned assets are in compliance with the study protocol, study operation plans, ich current gcps, and regulatory requirementsThey will work collaboratively with the sponsor clinical project manager (cpm), clinical research organization (cro) representative(s), vendors and other sponsor functional departments (as required) to drive start-up and ongoing oversight of clinical studies.
Key responsibilities:
Participate in the planning, implementation and management of sponsor clinical trials/assets in compliance with industry regulations, ich-gcp and applicable sponsor controlled documents.
Oversee the site management of cros and clinical trial sites to ensure delivery, per scope of work or contractual agreements, meet recruitment targets and deliver high quality data on time.
Track site visit and trip report metrics; data quality concerns and site level trending of protocol deviations.
Conduct oversight site visits including pharmacy visits, as required, to evaluate site and cra performance and ensure adherence to study protocols, study operation plans, ich gcp and regulatory requirements
Attend and assist, as required, at initiation visits to confirm site training of therapeutic indication(s) and associated study procedures (e.gPharmacy training) and help build and foster sponsor-cro-lnvestigator-site relationships
Review a percentage of cra monitoring trip reports, ensuring oversight of cro cra and site compliance with protocol, study plans, sops and ich and gcps, escalate identified report issues and ensure cro study team resolve identified concerns
Collaborate with sponsor cpm and medical monitor for country and site identification, feasibility and selection to optimize processes to ensure efficient start-up timelines are met.
Support study start up in collaboration with internal and external project teams (e.gProject manager, regulatory, clinical supplies, third party vendors, cro) to ensure start up timelines are clearly defined and implemented, working to identify any risks and resolving any issues.
Act as subject matter expert for assigned protocols for study related issues, protocol and clinical operational queries arising from cro, irb/iecs/ras, third party vendors and sites.
Support the cro/clinical trial site during start-up activities including, but not limited to, budget and contract negotiations, irb/ec submissions and response and facilitation of essential document collection
Support cpm to ensure consistency of clinical operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate.
Contribute to the development and/or participate in the review of study related documents including (but not limited to) site feasibility, informed consent documents (site specific), monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals and training materials
Execute and/or deliver trial specific training as required
Review of open action items and data trends; working with cros to escalate and resolve identified issues to ensure standards for monitoring and reporting are met as well as to ensure better efficiencies and execution of our studies.
Contribute to the development of and oversee implementation of patient recruitment and retention strategies and acts on any deviations from plan.
Other duties:
Support study team with site selection while optimizing start-up processes to ensure efficient start-up time lines are metAttend and present at investigator meetings on clinical operations topics, as required
May oversee the accurate, timely, and complete tracking of laboratory samples
May represent clinical operations in cross-functional initiatives (e.g., start-up, continued process improvements with cros).
Contribute to the development and/or participate in the review of sops, work instructions and team policies
Contribute to preparation of investigator newsletters or email newsflashes.
Supports the internal and external project teams with audits/inspection readiness and activities, resolution of audit/inspection findings and contribution to capas as required.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
Experience:
At least 5 years of relevant clinical operational experience in a
Biotechnology/pharmaceutical company, and/or cro
Working knowledge of gcp, ich, gdp and relevant cfrs is required; familiarity with mhra/ema/chmp regulations and guidelines and other international regulatory requirements is a plus
Experience with start-up and initiation of clinical trial sites
Experience creating and maintaining healthy and creative relationships with clinical trial sites and principal investigators, helping to support and influence where required
Ability to communicate and coordinate activities with the internal team, clinical sites and vendors
Ability to work independently with minimal supervision
Experience presenting high level presentations, both orally and in writing
Knowledge of and experience with immunotherapies and/or oncology
At least 2 years of on-site monitoring experience
Education & qualifications:
Educated to degree level (biological science, pharmacy or other health related discipline)
At least 5 years of relevant clinical operational experience in a
Biotechnology/pharmaceutical company, and/or cro
Demonstrated computer skills; proven functional knowledge of microsoft packages and ability to develop proficiency in relevant irt and edc systems and programs
