Junior Manger - Clinical Data Management Job in Syngene International Limited

JOB DESCRIPTION

Designation: Junior Manager Clinical Data Management
Job Location: Bangalore
Department: Clinical Development

About Syngene
Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job Purpose: To perform the data management activities like study setup to close out of the study and to conduct the data review on ongoing studies.

Key Responsibilities:
Responsible for execution of data management activities for all clinical projects.
Leading, mentoring and training data management team members.
Reviewing data management plan.
Providing inputs for proposal.
Performing quality checks for the data points.
Raising queries to clarify the discrepancy.
Updating the resolved queries in database for paper studies.
Initiating the process of data quality reviews.
Provide inputs for Case Report Form (CRF) designing.
Responsible for the quality of data that is being collected and processed.
Preparing and reviewing standard operating procedures.
To initiate the process of data quality review.
To delegate Biometrics personnel to act as a data quality reviewer for the specific study.
Conducting periodic performance appraisal for the direct reportee.
Completing any other responsibilities assigned by the organization from time to time.
Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety

Educational Qualification:
Graduate in Life Sciences
Masters in Life Science

Technical/functional Skills:
Should have hands on experience in Case Report Form (CRF) Designing, Study start up, Conduct and Close out activities.
Must have the good knowledge on The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practices (ICH-GCP).
Proficient in MS excel, MS word.
Attend training on environment, health, and safety (EHS) measures imparted company

Experience:
At least 5years of relevant Clinical Data Management experience

Behavioral Skills:
Good communication
Quick learner
Adapt to changes
Time management
Professionalism

Equal Opportunity Employer:
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.