Senior Clinical Data Manager

JOB DESCRIPTION

The Senior Clinical Data Manager (SCDM) is responsible for performing and assisting in data management activities like EDC build, coding, query management, external data reconciliation, SAE reconciliation, EDC testing and writing test scripts, and data cleaning. Act as backup to Lead Clinical Data Manager. If required, lead studies independently.

Support LDM in managing the work of outsourcing vendors and support LDM in approving the following key standard study documents: CCGs, Raw Data Validation Checks, User Acceptance Testing documents, eCRF development, and DB lock plans. Approve the key documents in the absence of LDM.

The SCDM should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; have an understanding of the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.

ESSENTIAL FUNCTIONS

• Perform and assist in data management activities like data validation, discrepancy review, query resolution, and reconciliation.
• Act as backup to Lead Clinical Data Manager. If required, lead studies independently.
• Support LCDM or independently prepare all study-specific procedures (DMP, CCG, etc).
• Create Data transfer agreements when required.
• Take part in study kick-off (internal and external) meetings.
• Review Case Report Forms (CRFs) and edit checks specifications.
• Ensure all deliverables meet quality standards and customer expectations
• Lead or support LCDM and coordinate other team members, providing guidance and support.
• Communicate with sponsors, sites, and other departments to facilitate data collection and resolve issues if required in the absence of LCDM.
• Assist LCDM in tracking and managing projects, identifying risks, and taking corrective actions.
• May provide training on basic data management expertise to new team members.
• Perform User Acceptance Testing (UAT)
• Provide regular study status updates to the LCDM.
• Support the LCDM in the delivery of study-specific training to all team members, ensuring that the training is documented, and the documentation is filed in the TMF.
• Train junior Clinical Data Managers, guide and help them through data management activities.

QUALIFICATIONS FOR ESSENTIAL FUNCTIONS

1. Ability to communicate effectively in the English language in person, by phone and in writing.

2. Ability to lead functional meetings.

3. Strong attention to detail and accuracy is a must.

4. Excellent organizational skills.

5. Demonstrated ability to manage multiple projects.

6. Ability to work collaboratively, effectively, and productively in diverse organization structures.

7. Ability to work independently, take initiative and complete tasks to deadlines: Delivering Excellence, Serving Customers, Accountability and Ownership, Global and Cross-Functional Communication.

8. Ability to work in a team-oriented, collaborative environment.

9. Ability to work positively within a continually changing environment.

10. Ability to effectively prioritize and execute tasks in a high-pressure environment.

11. Advanced computer skills and practical knowledge of MS Office and potentially project management software.

EDUCATION AND EXPERIENCE REQUIRED

1. A bachelor's degree in life sciences is required.

2. 5-7 years of core clinical data management experience is required.

3. Prior trial responsibility for the entire data management life-cycle is required.

4. Able to work in shifts. 9-6 PM IST for Local clients and 2-11 PM IST for US clients.

5. Study start-up and close-out experience is mandatory.

6. Experience working on different EDC systems (Medidata Rave, Veeva EDC, Oracle EDC, Medrio, etc)

7. Experience in multiple vendor reconciliations (Lab, ECG, PK, etc.) and integrations (IRT, Lab, and ECG integrations, etc.

8. Prior Study lead experience will be preferred.

9. Working knowledge of EDC studies is required, and SAS is preferred.

WORK REQUIREMENTS

1. Corporate office environment or remote.

2. Cross-functional interactions

TRAINING

• Complete Training Requirements per the current Training Requirements List.
• The supervisor may assign additional skills training, one-on-one, see-one / do one, or other Training as necessary to achieve qualifications and improve job performance.