Dr. Reddy's Laboratories looking for Senior Manager, Clinical Operations | Bridgewater, NJ - USA

Dr. Reddy's Laboratories (NYSE: RDY) is an emerging global pharmaceutical company with proven research capabilities. The company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection.

Post: Senior Manager, Clinical Operations

Job Description:
As a key member of the Clinical Development organization, this position will have a solid line reporting relationship to the Director of Clinical Operations. The responsibilities of this position will include the following:
Prepare, review and/or critique clinical study protocols (phase I-IV of clinical development).
Identify excellent investigational sites and/or contract research organizations.
Execute the request for proposal process.
Develop case report forms, informed consent forms, and site training documents.
Review study regulatory documents.
Assist in the management day to day conduct of clinical studies including handling questions from the sites and CROs about patient eligibility, protocol deviations, study supply shipments, recruiting issues, serious adverse events.
Interact with study sites to ensure accurate reporting of safety related issues associated with clinical trials.
Identify and communicate clinical research issues to pertinent parties.
Assist in the preparation of clinical study reports and scientific communications.
Facilitate contract process with CROs and other clinical services vendors.

Candidate Profile:
Approximate experience, or equivalent knowledge and skills, necessary to satisfactorily perform the position responsibilities.
Requires a BS degree; preferably from a U.S. recognized University, and preferably CRA certification.
At least 10+ years of experience in clinical research in the pharmaceutical industry including experience in preparing protocols and investigator site monitoring.
Requires some medical knowledge.
Requires ability to work in the USA and ex-USA.
Requires ability to travel up to 50% of time.
Excellent communication skills, written and verbal, in English.
Must have a working knowledge of GCP and FDA regulations.
Must have high energy level & be demanding of self and others.

Additional Information:
Location: Bridgewater, NJ
Experience: 10+ Years
Education: BS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job Code: 2583639
Last Date: 22^nd Sept., 2011