We are hiring a Clinical Study Manager!
The Clinical Study Manager (CSM) is responsible for the overall management of allocated clinical trials in the CRO department, in accordance with International Conference on Harmonization Good Clinical Practices (ICH-GCP), applicable regulations, SOPs and Wis.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Oversee global study coordination and ensure project timelines are met throughout all stages of the life cycle of a clinical trial.
- Oversee appropriate study global resources allocation – logistics, suppliers, and personnel.
- Supervise general trial conduct and general study recruitment rates.
- Develop, review, and oversee trial budgets.
- Outsource, review, and approve external study suppliers/vendors.
- Liaise with research sites, Sponsors, CRAs/Monitors, Study Suppliers, Laboratories and other support divisions to ensure quality and timely delivery of study deliverables.
- Writing, reviewing, and finalizing documents required for regulatory and ethical submission/approval/favourable opinion, including initial submission and amendments.
- Development of annual progression, safety and study close-out reports and/or delegate/coordinate/manage these tasks, as applicable.
- Develop trial risk assessments and appropriate risk management measures and/or delegate/coordinate/manage these tasks, as applicable.
- Local approval of trial-level documents (e.g. essential documents, forms, templates, SOPs, Case Report Forms, plans and reports).
- Supervise, coordinate and manage the development of CRFs for the collection of study data.
- Supervise the provision and Quality Control (QC) of Trial Master Files (TMF) and study archival procedures, as per applicable regulations and local SOPs.
- Planning, coordination and management of monitoring procedures, including developing monitoring plans and recruit appropriately trained clinical research associates (CRAs). Approve and manage monitoring processes (e.g. site activation, tracking of monitoring visits, approval of monitoring reports and follow-up letters). Perform central and remote monitoring activities, as required.
- Oversee and ensure appropriate pharmacovigilance reporting, as per regulatory requirements, study specifications and local SOPs.
- Supervise the processing of non-compliances, protocol deviations and the implementation of appropriate corrective and preventive actions (CAPAs) and reporting, as per applicable regulations, study specifications, and local SOPs.
- Maintain general oversight of all processes associated with the collection, shipping, analysis and reporting of study biological samples and other study clinical materials.
- Actively participate in improving the efficiency of the CRO quality management processes regarding study management.
- Manage study management team members (e.g. Clinical Trials Coordinators, Clinical Trials Assistants).
- Ensure study management team members comply with study protocols, GCP principles, applicable regulations and the local quality management system throughout all stages of a clinical trial life-cycle.
- PhD in Health or Life Sciences + 5 years (or Master in Health or Life Sciences + 7 years) work experience in clinical trials performing the main duties described above in a CRO/pharma company/Clinical Trials Unit
- Previous clinical trials management experience in a related position
- Knowledge of clinical trial and drug development processes
- Knowledge of Good Clinical Practices (GCP) and regulatory requirements applied to clinical research
Highly desirable skills:
- Ability to communicate with team members, clients and vendors and collaborate effectively with technical and senior management staff
- Supervising experience
- Strong interpersonal skills and a positive attitude
- Excellent written and verbal communication skills
- Excellent attention to detail
- Excellent administrative and IT skills
Please send CV to email@example.com