Talent.com
No longer accepting applications
Urgent! Clinical Data Manager (CDM)

Urgent! Clinical Data Manager (CDM)

TalentXpertPune, Maharashtra, India
10 days ago
Job description

I. Position Summary

The Senior Clinical Data Manager (CDM) is the Subject Matter Expert (SME) responsible for leading and executing all clinical data management activities from study startup through database lock. This role ensures all deliverables meet the highest standards of quality, are completed on time and within budget, and comply with all Standard Operating Procedures (SOPs), current industry, and regulatory guidelines (ICH, GCP, GCDMP). The CDM serves as the technical leader and primary contact for client and vendor communications.

II. Key Responsibilities

A. Study Leadership & Project Management

  • Independently manage the end-to-end delivery of Data Management services for single and multi-service clinical trial projects.
  • Serve as the primary liaison for internal teams, clients, and vendors, ensuring clear and effective communication throughout the study lifecycle.
  • Guide and mentor junior members of the Data Management team, including supervising and scheduling Data Management Associates.
  • Ensure data lock activities are performed according to agreed timelines, budget, and quality requirements.

B. Database Design & Setup (Design Phase Expertise)

  • Serve as the technical expert for eCRF design, ensuring alignment with the study protocol and data management guidelines.
  • Lead the execution of all study plans, from Data Management Plan (DMP) development through to database lock.
  • Design, maintain, monitor, and lock databases for diverse trials, including Phase I (First-in-Human, PK / PD, SAD / MAD), Safety & Tolerability studies, utilizing various EDC systems.
  • Apply in-depth knowledge of CDISC CDASH standards during database design and mapping.
  • C. Data Validation & Processing (Conduct Phase Expertise)

  • Oversee all data entry, data cleaning, and data transfer activities.
  • Implement and execute the Data Validation Plan (DVP) and create / maintain the Edit Check / Data Entry Guidelines (CCG / DEG) and Data Transfer Specifications (DTS).
  • Develop and validate SAS programs for data validation, and the creation of CDISC SDTM, ADaM, and Define-XML datasets.
  • Proactively identify and implement process improvements during study conduct (e.g., automating manual reconciliation processes like biomarker data checks) to improve efficiency and data quality.
  • D. Closeout & Submission Readiness

  • Ensure all necessary activities are performed during the conduct phase to guarantee a smooth and timely database lock and closeout.
  • Prepare and finalize data export files as required for statistical analysis and submission.
  • Maintain audit-ready documentation and ensure complete traceability of all data management processes.
  • III. Required Qualifications & Skills

    A. Experience

  • Minimum of 5 years of progressive experience in Clinical Data Management, with demonstrated ability to independently manage entire studies.
  • Proven experience working across all clinical trial phases, including Study Design, Conduct, and Closeout.
  • B. Technical Expertise

  • Expert-level knowledge of all standard DM documents (DMP, DVP, CCG / DEG, DTS, Specs).
  • In-depth working knowledge of major EDC systems and study building processes.
  • Strong analytical, problem-solving, and technical skills in database programming (e.g., SQL, SAS).
  • In-depth knowledge of CDISC CDASH standards and their practical application in eCRF design and database build.
  • In-depth understanding of database structures.
  • C. Regulatory & Soft Skills

  • In-depth knowledge of clinical trial processes, ICH, GCP, and GCDMP (SCDM) guidelines.
  • Proven ability to provide leadership and think strategically to achieve business goals.
  • Strong organizational, planning, and time management skills with the ability to multitask under tight deadlines.
  • Excellent written and verbal communication skills.
  • Create a job alert for this search

    Urgent Manager • Pune, Maharashtra, India

    Related jobs
    • Promoted
    Clinical Data Manager (CDM)

    Clinical Data Manager (CDM)

    TalentXpertPune, Maharashtra, India
    The Senior Clinical Data Manager (CDM) is the Subject Matter Expert (SME) responsible for leading and executing all clinical data management activities from study startup through database lock.This...Show moreLast updated: 9 days ago
    • Promoted
    Wellness Manager - BAMS / BNYS

    Wellness Manager - BAMS / BNYS

    Atmantan Wellness CentreMulshi, Maharashtra, India
    About Atmantan Wellness Centre.Atmantan Wellness Centre is India’s award-winning integrated wellness destination, renowned for its evidence-based programs that blend modern science with ancient hea...Show moreLast updated: 5 days ago
    • Promoted
    AVP Clinical Operations | US Healthcare

    AVP Clinical Operations | US Healthcare

    Cotiviti IndiaPune, Maharashtra, India
    Hello, Please share your updated resume at gemini.Thank you Summary : We are currently seeking an AVP – Clinical Operations with excellent operational acumen and people management skills.AVP will...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Product Manager - Clinical Systems

    Product Manager - Clinical Systems

    Precision Medicine Grouppune, India
    Product Manager – Clinical Systems.Are you an experienced Project and Product Manager with a background in Clinical Systems space? Is ensuring customers have the support they need to manage their s...Show moreLast updated: less than 1 hour ago
    • Promoted
    Senior Medidata Developer - Clinical Data Management

    Senior Medidata Developer - Clinical Data Management

    Renovision Automation Services Pvt.Ltd.Pune
    Description : Position Overview : We are seeking a Senior Medidata Consultant / Developer with extensive ex...Show moreLast updated: 4 days ago
    • Promoted
    Audit Manager- Healthcare

    Audit Manager- Healthcare

    Citrin Cooperman India LLPPune, IN
    Job Title : A&A Manager (Assisted Living / Nursing Home / Healthcare).Citrin Cooperman is one of the largest accounting and consulting firms in the United States, and 4th among mid-Atlantic firms, with ...Show moreLast updated: 10 days ago
    • Promoted
    Dean - School of Medicine

    Dean - School of Medicine

    D Y Patil University Navi MumbaiTalegaon, Maharashtra, India
    Patil University is expanding its academic ecosystem with the establishment of a modern D.Patil University School of Medicine at Ambi, Talegaon. Our focus is on academic excellence, research, patien...Show moreLast updated: 30+ days ago
    • Promoted
    Salesforce CPQ Developer

    Salesforce CPQ Developer

    InfoBeansPune / Pimpri-Chinchwad Area, India
    Position name # 1 : Salesforce CPQ Developer.Location : Pune (Hybrid / Remote).Demonstrate expertise in Salesforce platform architecture, data model, integration. Experience in Salesforce CPQ, Apex cla...Show moreLast updated: 7 days ago
    • Promoted
    Clinical Data Programmer - SAS + Elluminate

    Clinical Data Programmer - SAS + Elluminate

    SIROPune, IN
    Create and / or review derive data specifications as per the standards for SDTM, ADaM datasets and pooled analysis (ISS / ISE) datasets. Experience with Principal SQL + Elluminate.Experience with R Pro...Show moreLast updated: 30+ days ago
    • Promoted
    Delivery Manager

    Delivery Manager

    RecroPune, Maharashtra, India
    Proven experience with patient and / or payer data management solutions in the US pharmaceutical market.Microsoft Office suite (PowerPoint, Word). HIPAA-compliant data management experience.Experience...Show moreLast updated: 30+ days ago
    • Promoted
    Data Modeler

    Data Modeler

    Persistent SystemsPune, Maharashtra, India
    The Data Modeler will be responsible for designing and managing data models across cloud platforms, with a strong focus on Azure technologies. The role demands expertise in data migration, moderniza...Show moreLast updated: 30+ days ago
    • Promoted
    Data Science Lead, Clinical Intelligence

    Data Science Lead, Clinical Intelligence

    Anervea.AIPune, Maharashtra, India
    Job Description : Data Science Lead, Clinical Intelligence.Anervea is a pioneering AI transformation tech company delivering AI-powered SaaS solutions for the US pharma industry.Our therapy-agnostic...Show moreLast updated: 30+ days ago
    • Promoted
    Medidata Coder || 2-5 Years Experienced & Medidata Analyst || 7 - 10 Years Experienced

    Medidata Coder || 2-5 Years Experienced & Medidata Analyst || 7 - 10 Years Experienced

    Quantum IntegratorsPune, Maharashtra, India
    Location : Pune / Nagpur Offshore with a possibility of Onsite based on resource availability.Perform coding activities within the. Support the configuration and maintenance of Medidata applications....Show moreLast updated: 8 days ago
    • Promoted
    Medidata Analyst

    Medidata Analyst

    Quantum IntegratorsPune, Maharashtra, India
    Quantum Integrators is an international strategy and business consulting group whose mission is to help clients create and sustain competitive advantage. As a truly client-focused firm, our highly t...Show moreLast updated: 8 days ago
    • Promoted
    Clinical Data Configurator (SAS / SQL + R-Shiny)

    Clinical Data Configurator (SAS / SQL + R-Shiny)

    SIROPune, IN
    Create and / or review derive data specifications as per the standards for SDTM, ADaM datasets and pooled analysis (ISS / ISE) datasets. Perform development and validation of analysis dataset, tables, ...Show moreLast updated: 30+ days ago
    • Promoted
    2856 - Data Catalog and Governance - Collibra specialist

    2856 - Data Catalog and Governance - Collibra specialist

    EXLPune, Maharashtra, India
    Years of Experience - 5+ years.Location - Pune, Hyderabad, Bangalore, Noida and Gurugram.Hands-on experience with Collibra. Data Intelligence Platform, including : .Workflow configuration and customiz...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    For a Leading AMC - Manager Data Analytics

    For a Leading AMC - Manager Data Analytics

    Skill Ventorypune, India
    Benchmarking performance against targets across all marketing channels and advising on KPIs based on performance analysis. Reporting on key metrics, analysing and interpreting trends, and providing ...Show moreLast updated: less than 1 hour ago
    • Promoted
    Manager - CRM

    Manager - CRM

    EmeritusPune, IN
    Emeritus is committed to teaching the skills of the future by making high-quality education accessible and affordable to individuals, companies, and governments around the world.It does this by col...Show moreLast updated: 6 days ago