KlinEra has been partnering with pharmaceutical, biotech and device companies since 1999, providing innovative and customized clinical services to their client’s. Today, a decade’s presence in the Clinical Research Arena has made it a mature, comprehensive, creditworthy clinical research organization with offices in Mumbai, India and in San Jose, CA, USA. KlinEra offers a broad spectrum of integrated clinical research services through its dedicated and robust team of accomplished clinical researchers and optimizing cutting edge resources to cater to diverse global demands.
Post: Project Manager I and II
Job Description:
-Managing the Clinical Project Team
-Liaison with the Sponsor
-Managing clinical research sites.
-Executing clinical protocols and overseeing proper collection of data.
- Monitor ongoing compliance to study protocols, FDA Regulations, DCGI and IRB/EC requirements.
-Manage team of Clinical Research Associates, Clinical Trial Lead and Clinical Trial Assistants
-Work with management to implement department policies and procedures.
-Participate in the preparation of technical and scientific publications and provide ongoing analysis and synthesis of collected data.
-Preparing accurate and timely reports to management.
-Assist in the development and maintenance of computerized data collection system. Oversee proper collection of data.
-Complete projects and tasks in a manner consistent with corporate objectives and meet study timelines.
-Recommend and implement methods of improving processes and addressing problems in the clinical department.
Candidate Profile:
-BS preferred in Pharmacy, Life Sciences or any medical discipline.
-PG and MBA would be preferred
-Minimum 8 years experience in the clinical research industry.
-Minimum 3 years project management experience managing teams and multiple projects
-Excellent written and verbal communication skills.
-Knowledge of DCGI, USFDA and International regulatory requirements.
-May require travel up to 30% of time.
-Cardiovascular experience will be preferred
Additional Information:
Experience: MIn. 7 years
Location: Mumbai
Education: B.S, M.S, B.Pharm, MBA
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area : CR
End Date: 29th Jan, 2012
To Apply/Send resume, info@klinera.com
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