Share this Job

Sr Mgr. Global Clinical Project Management

Date: Nov 22, 2022

Location: Netanya, IL, 1

Company: Teva Pharmaceuticals

Who are we?

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

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

Qualifications

Education Required:    BA degree (preferred Graduate/MSc degree) in applicable discipline and a minimum of 5 years of related experience 
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 

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

Function

Research & Development

Sub Function

Clinical Development

Reports To

In process of validation

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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.