Lead Clinical Data Manager

JOB DESCRIPTION

The Lead Clinical Data Manager (LCDM) oversees all project management documentation and clinical data management activities, ensuring the quality and integrity of the final locked clinical database. The LCDM manages all clinical data management operations, including database audits, coding, SAE reconciliation, system and module testing, data cleaning, and database locking/unlocking.

The LCDM ensures other Data Managers are trained and supervises the quality of database setup, including essential documents and activities. They manage outsourcing vendors and approve key study documents, such as CCGs, Raw Data Validation Checks, User Acceptance Testing documents, eCRF development, and database lock plans.

The LCDM must thoroughly understand Good Clinical Data Management requirements and documentation, actively participate in the startup and closeout of in-house and client-specific data management projects, and possess strong knowledge of therapeutic indications, study hypotheses, trial design, database design, and structure.

ESSENTIAL FUNCTIONS

• Main point of contact for all the data management deliverables for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction.
• Lead data management projects, oversee study progress, quality of work, quality check processes, and essential documents.
• Communicate with sponsors, sites, and other departments to facilitate data collection and resolve issues.
• Communicate lessons learned and/or present in CDM workshop(s)
• Lead DM kick-off meetings and point of DM contact in cross-functional team meetings.
• Manage SOW and track the project status and finance health monthly, and participate in project reviews as requested - identify out-of-scope tasks and track change orders to completion.
• Main point of contact for financial tracking, revenue recognition, and invoicing. Oversee the monthly study hours and communicate with the finance team for invoicing.
• Should be able to take up a project manager role and coordinate with multiple teams like DM, SAS, and the Biostats team.
• Create project timelines aligning with cross-functional team activities.
• Assist in tracking and managing projects, identifying risks, and taking corrective actions.
• May provide training in basic data management expertise to new team members.
• Assist the Manager, CDM, and VP in process improvements and automations.
• 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 organizational 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 science is required.

2. 7-10 years of core clinical data management experience is required, 2+ years of study lead experience is required.

3. Prior experience in leading studies is required.

4. Prior experience in leading Study start-up and close-out activities is required.

5. Experience working on different EDC systems (Medidata Rave, Veeva EDC, Oracle EDC, Medrio etc is required.

6. Experience in multiple vendor reconciliations (Lab, ECG, PK, etc) is required.

7. Prior Integrations (IRT, Lab, and ECG integrations, etc) experience is required.

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

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.