Sportism - Clinical Research & Data ManagerSportism • Chennai, India
Sportism - Clinical Research & Data Manager
Sportism • Chennai, India
30+ days ago
Job descriptionManage 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. 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. 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. 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. 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. 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. 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. Expert-level proficiency in Microsoft Excel (advanced functions, macros, data analysis). Advanced Microsoft Word and PowerPoint skills for reporting and presentations. Exceptional written and verbal communication skills in English. Proven ability to present complex information to diverse audiences. Strong negotiation and relationship management capabilities. 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.
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
Data Management Oversight
Stakeholder Management
Required 10-12 years of experience in clinical trial / data management and data operations.
Technical Expertise
Leadership & Management Skills
Core Competencies
Technical Skills
Communication Skills
Educational Background
(ref : iimjobs.com)
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Clinical Data Manager • Chennai, India
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