Senior Manager Clinical Operations

58614 - Senior Manager Clinical Operations

The opportunity:

The Sr. Manager is responsible to lead and oversee the operational execution of Teva’s clinical studies from Phase I to Phase IV, in terms of cost, quality, timeliness and efficiency, while assuring patient safety and data quality and integrity.

How you’ll spend your day:

• Lead the development of the operational plans for clinical deliverables for assigned complex and/or multiple studies in parallel, effectively implementing design excellence in line with the Clinical Development Plan (CDP) and ensuring the principles of Good Clinical Practice (GCP).
• Ensure operational plans and activities are in line within the assigned studies.
• Collaborate with CQA to establish an auditing plan for assigned studies to ensure timely resolution of CQA audit findings at the global study or program level and collaborate with Inspection readiness to ensure study is ready for inspection (if applicable).
• Accountable for the performance and results of global studies, including:
• May provide direct management, career development and training of Clinical Project Managers (CPMs) and other GCO staff responsible for the timely execution of high quality clinical studies within budget and according to SOPs.
• Foster a collaborative, innovative, problems-solving culture with cross-functional team members for timely and high quality execution of studies.
• Review clinical outsourcing specifications and ensure review and approval by program or TA lead.
• Manage the CROs, vendors and consultants, working closely with Procurement for performance and quality metrics.
• Conduct and/or ensure completion of all oversight activities (e.g. oversight site visits, monitoring report review) as per the study vendor management plan.
• Ensure the appropriate information is communicated to management including but not limited to KPIs, achievements, risks, and mitigation plans.
• Responsible to review and approve study budgets and provide long-term forecasting for operational activities and ensures approval by program or TA lead.
• Prepare recruitment projections and select countries and sites in collaboration with the study team and CRO.
• Ensure compliance with Quality standards (SOPs, GCP, etc.).
• Manage the study team meetings and actively interact with key interfaces such as Pharmacovigilance, Medical Affairs, Marketing, Regulatory, etc.
• Manage the meetings at the study level with the CRO and other vendors (if applicable).
• Plan and manage Investigators’ and Kick-off meetings in close collaboration with the Clinical Study Physician (CSP) and other functions, including the study vendors.
• Ensure that training and applicable Sponsor’s information and/or materials are provided to all CRO/vendor personnel participating in the conduct of the study.
• In case of premature study termination or temporary suspension, lead the appropriate follow-up, ensure the trial termination plan and distribution to the CRO/vendor as appropriate is accomplished in line with the applicable Sponsor’s SOP, regulatory and public relations requirements.
• Ensure that all essential documents are present and that the TMF is complete prior to transfer to Teva. Ensures a summary of the CSR is distributed to the relevant parties.
• Develop in-depth knowledge in the relevant indication and clinical trials methodology and apply the relevant information as appropriate in recommending changes to better satisfy business requirements
• Participate in global departmental core activity processes and tasks. May initiate and lead GCO activities requiring extensive experience and professional skills set in Clinical Operations.

Your experience and qualifications:

• BA degree (preferred Graduate/MSc degree) in applicable discipline and a minimum of 5 years of related experience
• At least 4 years of experience pharmaceutical industry or clinical research site based experience
• Knowledge of ICH GCP guidelines
• Computer literate
• Fluent in English
• Experience Preferred:
• Global trial experience preferred
• Monitoring experience preferred
• Must be able to travel with overnight stays, as necessary, travel up to 30%