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Associate Clinical Data Manager
6-11 years
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Associate Clinical Data Manager
Novotech
posted 8d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Brief description of the role:
The core responsibility for this position is as a member of Novotech s Data Management group. The Associate Clinical Data Manager s (ACDM s) role is to control all aspects of data management under the guidance of a (senior) CDM and/or Line Manager and to ensure compliance with Good Clinical Data Management Practices (GCDMP).
Responsibilities:
Member of the project team reporting to the Biometrics Project Manager/Project Manager on projects, the Associate Clinical Data Manager is responsible for planning, conducting and managing of all aspects of data management for a clinical trial according to the client specifications, protocol, project plan, Data Management Plan, relevant GCDMP guidelines, regulatory requirements and SOPs.
Tasks under the guidance of a (senior) CDM and/or Line Manager:
- Determination of project feasibility from a data management perspective. Understand the requirements of the project agreement and scope to ensure that Novotech performs these services as required. If full service, then collaborate with PM to ensure appropriate mitigation and contingencies are initiated
- Participates in project team meetings as required.
- Input into the preparation of RFP s in liaison with BD and the clinical team.
- Liaison with the project team and client for preparing and maintaining Data Management Plans.
- Responsible for all aspects of data management including:
- Design and review of database structure, validation rules and consistency checks.
- Operation of Clinical Data Management software for data entry of clinical trial results.
- All data cleaning/validation tasks
- Development of all key Data Management Documents
- Liaison with client companies / monitoring staff as appropriate, ensuring effective study communication with internal and external stake holders
- Liaison with external service providers on Data Management projects as appropriate.
- Assist in the development of protocols as required.
- Perform accurate study financial projections and maintain monthly project financials.
- Ensure changes in scope are identified and actioned accordingly
- Active contribution to company business development initiatives, including involvement in the implementation of data management plans for business development in the company in general.
- Participation in industry forum (conferences, professional association committee work etc) as a means of professional development as well as promotion of Novotech s image in industry.
Independently perform the following tasks:
- Perform comprehensive data management tasks including data review, query management, external data reconciliation.
- Supervision and training support for junior and contract Data Management staff as required.
- Adherence to company Quality Policy and procedures as applicable to carrying out job responsibilities.
- Identification of and participation in process improvement initiatives, as required.
- Provide expert assistance and input into internal cross-functional projects including clinical research and regulatory affairs, as assigned.
- Project management of internal IT-based company projects as assigned (e.g. intranet development, client database applications etc.)
Qualifications:
- Graduate in a clinical or life sciences related field.
- At least three to six years experience working in a Clinical Data Associate (or equivalent) role in a pharmaceutical industry or related role.
Employment Type: Full Time, Permanent
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What people at Novotech are saying
Associate Clinical Data Manager salary at Novotech
reported by
2
employees
with 5-6
years exp.
₹8.4
L/yr - ₹9.7
L/yr
25%
less
than the average Associate Clinical Data Manager Salary in India
View more details
What Novotech employees are saying about work life
based on 55 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Novotech Benefits
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Associate Manager Accounts Payable
8-10 Yrs
Kolkata, Mumbai, New Delhi +4 more
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