Manager - Clinical Data Management

Position Overview
We are seeking an experienced Associate Manager - CDM to support our clinical data management team in Chennai. The successful candidate will work as Subject Matter Expert (SME) for CRIO CTMS including e-Source creation, edit, oversee and mentor the end-to-end clinical trial management system activities, ensuring seamless integration between CTMS, EDC platforms, and clinical operations

Key Responsibilities

CTMS Operations & Strategy
Develop and maintain e-source, CTMS workflows, user roles, and system permissions.
Ensure integration between CTMS and EDC systems for seamless data flow.
Lead system upgrades, validation activities, and change control processes.
Establish and monitor key performance indicators (KPIs) for CTMS operations.

Clinical Trial Management
Manage multiple clinical studies simultaneously from startup through closeout.
Mentor and oversee study setup activities in CRIO, should participate and provide inputs from CDM perspective in SIV, PSV & Study Kick off meetings.
Having knowledge of reading and understanding CTA, and regulatory submissions is preferred.
QC status tracking and follow up with respective stake holders.
Monitor study progress, enrollment metrics, and milestone achievements.
Coordinate with CRCs, clinical operations and regulatory affairs teams.
Ensure compliance with regulatory requirements and company SOPs.

Data Management Oversight
Supervise data entry activities from e-source documents (Real-time & CRIO) into EDC systems.
Establish quality control processes ensuring 100% data accuracy standards.
Oversee query management processes including raising, tracking, and resolution on day-to-day basis.
Manage third-party data vendor relationships and data transfer activities.
Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and local regulations.
Develop and update standard operating procedures (SOPs) as required.
Manage corrective and preventive action (CAPA) processes & RCA.

Stakeholder Management
Assist in presenting study status reports to senior management and clients.
Coordinate with IT teams for system enhancements and troubleshooting.
Facilitate communication between global and local teams.
Lead cross-functional initiatives and coordinate with various departments.

Required Qualifications
Experience
10-12 years of experience in clinical trial/data management and data operations.
Minimum 4-5 years of people management (preferred) experience with proven supervisory skills.
Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS, or similar).
Strong background in EDC systems management and clinical data operations.
Experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic areas.

Technical Expertise
CTMS configuration and administration skills (Having knowledge in CRIO is an advantage).
Deep knowledge of EDC platforms and system integrations.
Strong understanding of regulatory requirements (HIPPA, FDA, EMA, ICH-GCP).
Experience with electronic systems validation and 21 CFR Part 11 compliance.

Leadership & Management Skills
Skilled in handling high-pressure situations while consistently meeting deadlines.
Experience managing cross-functional teams and supporting matrix organizations.
Strong process improvement and operational efficiency capabilities.
Good conflict resolution and collaborative decision-making skills.
Ability to mentor and develop team members at various experience levels.

Core Competencies
Strategic Thinking: Ability to align operational activities with business objectives.
Process Optimization: Experience in streamlining workflows and improving efficiency.
Risk Management: Proactive identification and mitigation of operational risks.
Analytical Skills: Data-driven decision making and performance analysis.
Communication Excellence: Strong presentation and stakeholder management abilities.
Quality Leadership: Commitment to maintaining 100% quality standards across all deliverables.
Adaptability: Ability to thrive in fast-paced, evolving regulatory environments.

Technical Skills
Expert-level proficiency in Microsoft Excel (advanced functions, macros, data analysis).
Advanced Microsoft Word and PowerPoint skills for reporting and presentations.

Communication Skills
Exceptional written and verbal communication skills in English.
Proven ability to present complex information to diverse audiences.
Strong negotiation and relationship management capabilities.

Educational Background
Bachelor's degree in Life Sciences, Health Sciences, Nursing, Pharmacy, Medicine, Engineering, or related field.
Master's degree preferred (MBA, MS in Clinical Research, or equivalent).
Certified CRC and CCDM qualifications are desirable.