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
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Required QualificationsExperience
- 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.
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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.
