Lead Clinical Data Manager

The Role :

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 project manager role and coordinate with multiple teams like DM, SAS and 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 Manager, CDM and VP in process improvements and automations.
• Train junior Clinical Data Managers, guide and help them through data management activities.

Ideal Profile :

QUALIFICATIONS FOR ESSENTIAL FUNCTIONS

EDUCATION AND EXPERIENCE REQUIRED

WORK REQUIREMENTS

1. Corporate office environment or remote.

2. Cross-functional interactions

TRAINING

What's on Offer?