Sr Manager Clinical Operations

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

This position is hybrid and requires 3 days in the West Chester, PA office.

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.
Travel Requirements:  Must be able to travel with overnight stays, as necessary, travel up to 20%

 

Essential Duties & Responsibilities:

• 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.

Your experience and qualifications

Education Required:    
BA degree (preferred Graduate/MSc degree) in applicable discipline and a minimum of 5 years of related experience.  Note: Any equivalent combination of education, training and/or experience that fulfills the requirements of the position may be considered.  

 

Experience Required:    

• 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 

Enjoy a more rewarding choice

We offer a competitive benefits package, including Medical, Dental, Vi