Sportism - Clinical Research & Data Manager

OverviewWe 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 operationsKey ResponsibilitiesCTMS 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 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. (ref:iimjobs.com)