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Senior Manager Clinical Operations

Date: Mar 3, 2019

Location: Frazer, Pennsylvania, US, 19355

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

  • Oversee the development of the operational plans for clinical deliverables for assigned studies, effectively implementing design excellence in line with the study protocol and ensuring the principles of GCP.
  • Collaborate with CQA to establish a study auditing plan to ensure timely resolution of CQA audit findings at the global study and collaborate with Inspection readiness to ensure  study is ready for inspection (if applicable).
  • Accountable for the performance and results of global studies, including:
    • Foster a collaborative, innovative, problems-solving culture with cross-functional team members for timely and high quality execution of studies.
    • Manage the third party vendors 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
    • Prepare recruitment projection and select countries and sites in collaboration with the study team and CRO.
    • Ensure compliance with Quality standards (SOPs, GCP, etc.).
    • Manage the meetings at the study level with the CRO and other vendors
    • Plan and manage Investigators and Kick-off meetings in close collaboration with the Study Physician and other functions, including the study vendors.
    • Ensure that training and/or materials are provided to all CRO/vendor personnel participating in the conduct of the study.
    • Ensure the TMF is complete prior to transfer to Teva. 
    • May participate in global departmental core activity processes and tasks

 

 

Qualifications

BA 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

Global trial experience preferred

Monitoring experience preferred

Must be able to travel with overnight stays, as necessary, travel up to 30%

Function

Research & Development

Sub Function

Reports To

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: Philadelphia

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