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Senior Manager Clinical Operations

Date: Jan 10, 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

Position Summary:  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.

Essential Duties & Responsibilities:

1.

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).

2.

Ensure operational plans and activities are in line within the assigned studies.

3.

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).

4.

Accountable for the performance and results of global studies, including:

  1. 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.
  2. Foster a collaborative, innovative, problems-solving culture with cross-functional team members for timely and high quality execution of studies.
  3. Review clinical outsourcing specifications and ensure review and approval by program or TA lead.
  4. Manage the CROs, vendors and consultants, working closely with Procurement for performance and quality metrics.
  5. Conduct and/or ensure completion of all oversight activities (e.g. oversight site visits, monitoring report review) as per the study vendor management plan.
  6. Ensure the appropriate information is communicated to management including but not limited to KPIs, achievements, risks, and mitigation plans.
  7. Responsible to review and approve study budgets and provide long-term forecasting for operational activities and ensures approval by program or TA lead.
  8. Prepare recruitment projections and select countries and sites in collaboration with the study team and CRO.
  9. Ensure compliance with Quality standards (SOPs, GCP, etc.).
  10. Manage the study team meetings and actively interact with key interfaces such as Pharmacovigilance, Medical Affairs, Marketing, Regulatory, etc.
  11. Manage the meetings at the study level with the CRO and other vendors (if applicable).
  12. Plan and manage Investigators’ and Kick-off meetings in close collaboration with the Clinical Study Physician (CSP) and other functions, including  the study vendors.
  13. 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.

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

Global trial experience preferred

Monitoring experience preferred

 

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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: Philadelphia

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