The CTOM is responsible for overall operational activities and planning for the implementation and conduct of assigned clinical studies (registration studies, LCM studies, observational trials, compassionate use and registries) including data management activities in compliance with GCP's, SOPs and standards within established timelines. The CTOM is involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee release of homogeneous high quality data, in close collaboration with Medical Operations representative.

Major Duties and Responsibilities
Provide oversight of a clinical trial or trials to ensure progress according to trial timelines. Collect, track, synthesize and report trial information.
Lead the clinical trial team (CTT) including representatives from CRUs/CROs, GPE, Medical Operation, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics and other relevant departments for the logistical aspects of the study. Liaise with the Feasibility Manager to review & assess country feasibility. Liaise with Clinical Purchasing to prepare the Request For Proposals (RFP), review vendor specifications, and oversee vendor activities and deliverables (i.e. central lab, IVRS, CRO). Maintain and provide monthly study highlights, enrollment curves, OPX timelines and key trial data (i.e. efficacy, safety, pharmacokinetics, pharmacodynamic parameters).  Ensure proper generation of documentation.  Contribute to the protocol and amendments to ensure operational feasibility. Lead the development of Case Report Form CRF. Develop study-specific procedures and write the Monitoring Plan, the Data Management Plan, the Data Validation Plan, the Data Review & Surveillance Plan and/or other operational documents in conjunction with the CTT.
Review other CTT-developed documents as requested to provide operational input (including on-time and high quality). Ensure that clinical and data management standards are followed for the study.  Ensure proper overview (including on-time and high quality) of monitoring activities, data flow, data validation and when applicable, coordinates the centralized review of procedures. Review data validation plan in conjunction with the CTT.  Ensure trial documentation is properly maintained and archived in the Trial Master File (TMF) and relevant e-Rooms and databases as required.
Train and Develop Monitoring Team on study specific procedures and coordinate field-monitoring activities.  Coordinate and support field-monitoring activities through regular meetings: teleconferences and/ or visits to CRU's, training of CRAs, investigator meetings. CRO management if applicable. Participate in the development of the clinical trial budget and, selection and management of vendors.  Define needs, tasks and responsibilities of external resources, review contracts, estimate costs of logistical aspects of the trial and tracking payments for operational aspects of the trial in collaboration with the Clinical Purchasing department. Set up and track clinical trial budget (AED). Participate in vendor analysis and selection for a trial. Manage external resources for trial. Investigational Product (IP) Management.  Collaborate with the CIP Dept. to validate IP needs, specifications, packaging, shipment (including resupply) and reconciliation process. Preparation and oversight of trial audits/inspections (internal and external) and for FDA pre-approval inspections (PAI).  Ensure proper responses to audit/inspection reports & consolidation of findings. Coordinate and implement PAI preparation plan.

 Knowledge and Skills Required

- Excellent interpersonal and communication skills (verbal and written)
- Ability to handle multiple tasks and to prioritize. Strong organizational and presentation skills
- Leadership & project management skills
- Decision-making and problem-solving skills
- Ability to work autonomously and to efficiently & effectively provide status reports
- Ability to anticipate and timely escalate issues and to define appropriate action plans
- Good cross-functional team leader who fosters team spirit and team motivation (team work)
- Knowledge and qualification with international standards (e.g GCP, CDISC…), company tools (including data management systems), processes and SOPs
- Management of international meetings (Clinical Trial Team, expert meeting….)
- Ability to work in an international environment with internal and/or external partners (CROs…)

Formal Education Required
Bachelor's degree (advanced degree preferred) and 8 years of clinical research experience in the pharmaceutical industry (or equivalent) is required. At least two years of Project Management experience in Clinical Operations and 5 years of experience in Oncology are required.