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Post : Senior Site Manager
Position Summary:
- Global Clinical Operations (GCO) India, Janssen Research and Development is recruiting for a Senior Site Manager. This position can be located in the GCO India Mumbai, India.
- At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
- Janssen Research & Development, discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
- The Senior Site Manager will be responsible for site recruitment, patient recruitment and retention planning, site initiation, monitoring and close-out. Ensure study related activities in compliance with all Clinical Operations, Standard Operating Procedures (SOPs), policies and regulatory requirements from Start-Up through Data-Base Lock. Partner with trial team members to ensure overall site management while performing trial related activities for assigned protocols. Serve as primary point of contact and liaison between investigational site staff and study team once site is initiated. Represent functional area(s) in divisional/company-wide process initiatives.
Responsibilities :
- Participate in Site/Investigator feasibility, qualification and selection process by providing recommendations from local area.
- Execute activities within start-up, site monitoring, site management and site/study close-out, according to internal SOPs and policies.
- Write timely Visit Reports and submit via electronic Trial Master File (eTMF).
- Ensure site staff resolve data queries, and works with sites to ensure data timelines are met.
- Maintain accurate and timely data in systems utilized for clinical trial management (i.e. CTMS).
- Ensure timely and accurate data collection, documentation and communication of site/study progress and issues.
- Plan, conduct and document site staff training and monitors site performance.
- Present/participate in Investigator Meetings as needed.
- Monitor expiry date of Investigational Product and ensure study supply strategy is adequate.
- Mentor new hires with supervision and serve as Lead SM for a specific trial as needed.
- Review electronic Case Report Forms (eCRFs) and Completion Guidelines and participate in Electronic Data Capture (EDC) User Acceptance Testing (UAT) testing and special initiatives as needed.
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Candidate Profile
- A minimum of a Bachelor’s degree in a Health or Science discipline is required.
- A minimum of 6 years of clinical trial monitoring experience is required.
- Clinical research monitoring experience with any of the following Therapeutic Areas preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases, Vaccines.
- Experience with Phase II and Phase III Clinical Trials required.
- Strong knowledge of the drug development process, including Good Clinical Practices (GCPs) and local regulations, is required. Experience working with computer software applications is required.
- Must have strong written and oral communication skills.
- Willingness to travel 50%, approximately 2-3 days per week, with overnight stays (1-2 nights on average), is required.
Additional Information:
Location: Maharashtra-Greater Mumbai
Education: Bachelor’s degree in a Health or Science
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Clinical Trial Administration
Job Code: 1700200074W
End Date: 19th November, 2017
To Apply Online Click Here
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