Description:

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, Pharmacy, Medicine, Engineering, or related field.

- Master's degree preferred (MBA, MS in Clinical Research, or equivalent).

- Certified CRC and CCDM qualifications are desirable.