I am recruiting for a Clinical Operations Program Leader for a multinational pharmaceutical, they are a European leader and one of the largest globally in their field.
Clinical Operations Program Leader
The role: Oversees the clinical feasibility assessment and strategic planning of clinical trial programs or studies. Executes on these global programs or studies in one or more assigned therapeutic area(s) from decision to start a clinical development up to the market authorization. Manages budgets, timelines and quality of deliverables for assigned program(s) and study(ies) in accordance with International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, applicable regulatory requirements, company standard operating procedures (SOPs), and study protocols
Location: Dublin, Ireland.
Salary: Excellent salary, bonus and benefits available.
* Oversees integrity of clinical data to ensure data meets GCP standards.
* Maintains good knowledge of the literature for the indication being studied and reviews and summarizes all published literature for the therapeutic area of interest.
* Provides clinical review/input to Investigator Sponsored Research proposals.
* Assesses best strategic path forward for a clinical program, identify risks, mitigations, opportunities and contingency plans for assigned program(s) and study(ies).
* Drafts clinical components from decision to start a clinical development and up to the market authorization (DP1-DP5) gates, liaise cross-functionally to provide clinical input on all development stages and Target Product Profile, as necessary.
* Manage Clinical Development trial team and contribute to training for clinical program
* Manages clinical timelines, budgets, and resources against the approved clinical development plan (CDP) in collaboration with contract manager.
* Supports the Program Manager in overseeing third party vendors performance (e.g., contract research organizations (CROs), central labs) including on time study completion, budget adherence, and quality deliverables.
* Contributes to the evaluation of the vendor performance to ensure early mitigation/resolution of potential issues and develops/implements corrective action plans as appropriate, along with the Program Manager
* Performs Sponsor Site Visits at selected sites to oversee the site and the monitoring performances, to increase the communication with the site and awareness of protocol burdens. Documentation of the Sponsor Visits and follow-up of appropriate corrective and preventive actions.
* Provides clinical review/input to clinical documents (e.g., protocols, investigator brochures, periodic safety reports and clinical study reports) and ensures the accuracy and integrity of clinical data prior to submission to regulatory authorities (e.g. Investigational New Drug (IND) application, Clinical Trial Application (CTA), Biologics License Application (BLA), Marketing Authorisation Application (MAA))
* Drafts or provides review/input for publications from clinical study data and white paper literature reviews on new products or safety questions.
* Partners with Biometry to develop the case report form, data management plan and statistical management plan. Ensure timely data transfers for data cleaning, review and analysis.
* Reviews protocol deviations and data listings to ensure integrity of data and identify trends on ongoing basis.
* Offers guidance to resolve escalated study conduct issues and provides clinical responses to questions from study centre personnel, regulatory authorities and institutional review boards/ethics committees.
* Oversees responses to vendor/site audits, as necessary.
* Manage and contribute to preparation of internal inspections, attends internal inspections, and manages responses to internal inspections.
* Supervises quality of the clinical trial and ensures implementation of Corrective and Preventive Actions to quality deviations and misconducts.
Your knowledge and experience:
* 10+ years of experience in clinical research, including 2 to 5 years in a study management/leadership role.
* Master's degree or higher-level degree in relevant discipline. (2-years' experience equivalence for a MD and 4-years' experience for a master's degree).
* Advanced leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel.
If you are interested in this Clinical Operations Program Leader position, please contact myself or my colleague John Finn, email@example.com, through LinkedIn or directly to arrange a confidential follow up call with myself: 00 353 (0) 87 6214254, firstname.lastname@example.org