Teva Pharmaceutical Industries Lid. (NASDAQ:TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as Innovative and specialty pharmaceuticals and active pharmaceutical Ingredients. Headquartered In Israel, leva Is the world's largest generic drug maker, with a global product portfolio of more than 1,250 molecules and a direct presence in approximately 60 countries. Teva employs about 40,000 people around the world and reached $13.9 billion in net sales in 2009. Since August 2010 ratlopharm Is a part of Teva group, ratlopharm India private limited produces solid oral dosage forms at Its manufacturing unit at Vema Goa. The following positions will be based in Goa.
Post: Regional Clinical Trial Manager
Job Description:
Overview
The primary responsibility of the RCTM is to oversee and manage single-center studies, healthy volunteer studies or single-country registrational trials and to oversee the conduct of global clinical trials at the regional level, for all clinical phases, in partnership with the Clinical Project Manager (CPM).
Responsibilities
- Assists in selection and approving the countries and centers for assigned clinical studies within the region
- Prepares recruitment projections and assures that these are met with the CPM and CRO
- Prepares study specific budgets and monitors these budgets if the study is being managed by the region
- Is involved in eligibility process
- Reports on the progress of the trials
- Takes part in global study team meetings with the CPM and CRO as the regional representative
- Manages study team meetings with the CRO if the study is being managed by the region
- Provides sponsor oversight - and supports global trials within the region by working as a partner with the CPM
- Establishes active network with the key opinion leaders in the field within the region
- Ensures compliance with Quality standards (SOP's, GCP, etc.)
- Develops in-depth knowledge in relevant indications and clinical trials methodology
- Collaborates with other Teva functions such as Phamacovigilence, Medical Affairs, Marketing, Regulatory etc. at the regional level
- Communicates with the CRO, vendors and supporting functions at the regional level in partnership with the CPM
- Assists or controls financial agreements and arranges timely payment of fees via the CRO
- Any other task assigned by direct manager
Candidate Profile
Education and Knowledge Requirements:
- College degree or higher, preferentially in sciences/medical sciences
- At least 4 years of experience as Clinical Trial Manager
- At least 1 year of monitoring experiance
- Clinical trial operations experience across therapeutic areas preferred (e.g oncology, clin pharm, CNS, biosimilars, internal medicine)
- Knowledge of ICH GCP guidelines and local regulations for the particular Region
- Computer literate
- Fluent in English
Note: Any equivalent combination of education, training and/or experience that fulfills the requirements of the position may be considered.
- Must be able to travel (at least 30%)
Competencies:
- Strong communication and organizational skills
- Strong management and motivation skills
- Ability to manage study teams and perform issue escalation
- Flexible and able to work with deadllines
- Team player who can also operate alone
- Solution-oriented and problem solving attitude
- Vendor/CRO and budget management skills
- Knowledge of trial budget management and patient fees
Location: US-PA-Frazer
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