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Sportism - Clinical Research & Data Manager

Sportism - Clinical Research & Data Manager

SportismChennai, India
5 days ago
Job description

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 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)

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