Talent.com
Senior Clinical Data Manager
Senior Clinical Data ManagerEverest Clinical Research Services Inc • Philippines, undefined, PHL
Senior Clinical Data Manager

Senior Clinical Data Manager

Everest Clinical Research Services Inc • Philippines, undefined, PHL
30+ days ago
Job description

Everest's global biometrics team is embarking on an exciting phase of growth and we are looking to expand operations to the Philippines. If you’re driven by data, eager to make a meaningful impact, and want to be part of a Statistical and Data Management Center of Excellence, we invite you to join our global biometrics team and help shape the future of clinical research.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Data Managers remotely from a home-based office near Manila, Philippines, in accordance with our Work from Home policy.

Key Accountabilities :

Lead Data Management Activities, Perform Training and Client Relationship Management

  • Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions.
  • Is the primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects.
  • Is the primary contact person for communication and discussion of topics related to data management timelines and deliverables; request for out of scope tasks; first line contact for technical or procedural issues.
  • Is responsible for planning and implementing data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting.
  • Assist with study-level resource planning and management, including the review of team members’ timesheet reports.
  • Assist in performing client relationship management activities. Participate in project bid defense meeting when required.
  • Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel.
  • Provide training to new data management personnel on data management processes and procedures. Perform QC review of work performed by less experienced data management personnel.
  • Assist in generation of project Work Orders and Amendments.
  • Assist in management of dataflow from and performance of Third Party Vendors (Non-CRF data vendors).
  • Participate in project kick off meeting, investigators meeting, and regular project management team meeting.
  • Provide support to client audits and regulatory inspections. Follow up on audit findings.
  • Create and maintain clinical trial Data Management Study Binders.

Perform Hands-on Data Management Activities

  • Design and review case report forms (CRFs / eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms.
  • Design and review Clinical Trial Source Document templates and completion instructions when required.
  • Develop and maintain data validation specifications.
  • Develop and maintain Data Management Plan (DMP). Document deviations from the DMP.
  • Participate in the database design process. Participate in EDC User Acceptance Testing (UAT).
  • Manage the process of database modifications (after go-live) due to protocol amendments or study needs.
  • Develop and maintain Data Quality Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of the listings and summary tables as specified in the DQRP.
  • Perform Third Party non-CRF data management activities.
  • Review data, issue and resolve queries. Assist Investigative Site personnel with resolving queries.
  • Perform Serious Adverse Event reconciliation.
  • Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products.
  • Cooperate and assist the Quality Assurance Department with quality control audits on assigned databases.
  • Perform database soft-lock and hard lock activities.
  • Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving such documentation.
  • Qualifications and Experience :

  • A Bachelors’ or Master’s degree in health and / or pharmaceutical sciences, physical / biological, or chemistry fields.
  • At least 5 years of experience in pharmaceutical clinical trial data management or at least 2 year of experience as a Clinical Data Manager II, with demonstrated knowledge, experience and ability to perform to meet high quality standards and high level of customer satisfaction.
  • Demonstrated an in-depth understanding of clinical trial data management concepts, processes and procedures, relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions and standards
  • Demonstrated a strong leadership in clinical data management activities and a desire to excel in leading data management projects.
  • Create a job alert for this search

    Clinical Data Manager • Philippines, undefined, PHL

    Similar jobs
    NetSuite Consulting Delivery Manager

    NetSuite Consulting Delivery Manager

    Oracle • , , Philippines, Philippines
    NetSuite Consulting Delivery Manager.Join to apply for the NetSuite Consulting Delivery Manager role at Oracle.Be among the first 25 applicants. As a leading contributor within the practice, this se...Show more
    Last updated: 14 days ago • Promoted
    Medical Scribe (Podiatry Experience)

    Medical Scribe (Podiatry Experience)

    Angel City VA • PH
    Quick Apply
    We are seeking an experienced Medical Scribe with expertise in Podiatry and proficiency in Dr Chrono EMR to join our dynamic healthcare team. The ideal candidate will play a vital role in supporting...Show more
    Last updated: 30+ days ago
    Retainer Cardiologist (Remote)

    Retainer Cardiologist (Remote)

    Hive Health Pte Ltd • , , Philippines, Philippines
    At Hive Health and HPPI, a subsidiary of Hive Health, we’re on a mission to make healthcare radically more accessible for all—and we need passionate, driven individuals to help us make it happen.If...Show more
    Last updated: 23 days ago • Promoted
    Senior Manager- Model Audit

    Senior Manager- Model Audit

    Gridlines • , , Philippines, Philippines
    Gridlines is a rapidly growing financial modelling consultancy practice.We are transforming the world of financial modelling, helping our clients to make complex financial decisions quickly and wit...Show more
    Last updated: 3 days ago • Promoted
    Senior Medical Coding Director — Lead Global Transformation

    Senior Medical Coding Director — Lead Global Transformation

    UnitedHealth Group • , , Philippines, Philippines
    A global healthcare organization is seeking a leader for a Medical Coding role in the Philippines.The ideal candidate will have a PHRN or MD, medical coding certification, and over 5 years of exper...Show more
    Last updated: 30+ days ago • Promoted
    Product Manager (Sr. Manager / Manager) - Ethical Pharma & OTC

    Product Manager (Sr. Manager / Manager) - Ethical Pharma & OTC

    Michael Page • , , Philippines, Philippines
    Opportunity for personal and professional growth.Experience to work in a renowned company.Get to work in a renowned pharmaceutical company!. Lead product strategy and lifecycle management for ethica...Show more
    Last updated: 30+ days ago • Promoted
    Senior Power BI Lead | Data Modeling & Analytics (Remote)

    Senior Power BI Lead | Data Modeling & Analytics (Remote)

    TASQ Staffing Solutions • , , Philippines, Philippines
    A staffing and consulting firm is seeking a Lead Consultant specializing in Power BI for a remote role.Ideal candidates will have over 5 years of experience in BI solutions, particularly within the...Show more
    Last updated: 1 day ago • Promoted
    Clinical Trials (Business Development Experienced)

    Clinical Trials (Business Development Experienced)

    Angel City VA • PH
    Quick Apply
    Now Hiring : Remote Business Development Specialist – Clinical Trials (Part-Time / Full-Time) ????.Are you a results-driven professional with a passion for healthcare and sales?.Join our team as...Show more
    Last updated: 30+ days ago
    Amazon Catalog Analyst – Remote- Mid Shift- HMO

    Amazon Catalog Analyst – Remote- Mid Shift- HMO

    Filta • , , Philippines, Philippines
    Amazon Catalog Analyst – Remote‑ Mid Shift‑ HMO.Location : Accepting candidates from Metro Manila, Pampanga / Clark, Cebu Only. Schedule : Monday to Friday, 3 : 00 PM – 12 : 00 PM PHT.Join a New York based ...Show more
    Last updated: 2 days ago • Promoted
    Clinical Research - Trials (GCP EDC Trained)

    Clinical Research - Trials (GCP EDC Trained)

    Angel City VA • PH
    Quick Apply
    Medical Virtual Assistant (GCP or EDC) - Must Know Clinical Trials Are you passionate about clinical trials and eager to make a difference in the medical field?. We are looking for a dedicated and s...Show more
    Last updated: 30+ days ago
    Remote Endocrinology Telemedicine Specialist

    Remote Endocrinology Telemedicine Specialist

    Hive Health Pte Ltd • , , Philippines, Philippines
    A healthcare innovation company is seeking a Board-Certified Internal Medicine Physician specializing in Endocrinology to join as a Remote Telemedicine Specialist. This fully remote role involves pr...Show more
    Last updated: 23 days ago • Promoted
    Remote Business Development Specialist – Clinical Trials (Part-Time / Full-Time)

    Remote Business Development Specialist – Clinical Trials (Part-Time / Full-Time)

    Angel City VA • PH
    Quick Apply
    Now Hiring : Remote Business Development Specialist – Clinical Trials (Part-Time / Full-Time) 📢 Are you a results-driven professional with a passion for healthcare and sales?.Join ...Show more
    Last updated: 30+ days ago
    External Audit Senior Manager

    External Audit Senior Manager

    PwC South Africa • , , Philippines, Philippines
    External Audit Senior Manager page is loaded## External Audit Senior Managerlocations : Makatitime type : Full timeposted on : Posted 30+ Days Agojob requisition id : WD • •Line of Service • •Assu...Show more
    Last updated: 30+ days ago • Promoted
    Technical Delivery Manager

    Technical Delivery Manager

    Cloud Assess • , , Philippines, Philippines
    Get AI-powered advice on this job and more exclusive features.Cloud Assess is a leading SaaS platform designed to power competency-based training, assessment, and workforce development.We help orga...Show more
    Last updated: 3 days ago • Promoted
    Remote GI & Liver Specialist — Telemedicine Leader

    Remote GI & Liver Specialist — Telemedicine Leader

    Hive Health Pte Ltd • , , Philippines, Philippines
    A leading healthcare technology company is seeking a Board-Certified Internal Medicine Physician specializing in Gastroenterology as a Remote Telemedicine Specialist. This 100% remote opportunity fo...Show more
    Last updated: 23 days ago • Promoted
    Senior Technical Delivery Lead - SaaS

    Senior Technical Delivery Lead - SaaS

    Cloud Assess • , , Philippines, Philippines
    A leading SaaS platform in the Philippines seeks a Senior Technical Delivery Manager responsible for ensuring end-to-end execution of engineering initiatives. This role requires strong communication...Show more
    Last updated: 3 days ago • Promoted
    Senior Manager, Financial Modelling & Client Impact

    Senior Manager, Financial Modelling & Client Impact

    Gridlines • , , Philippines, Philippines
    A financial consultancy is seeking a Manager – Financial Modelling to oversee a portfolio of assignments and lead financial model development. This role involves managing a team, ensuring high-quali...Show more
    Last updated: 2 days ago • Promoted
    PhD Data Partner - Biology - Asia | Fully Remote

    PhD Data Partner - Biology - Asia | Fully Remote

    TELUS Digital AI Data Solutions • , , Philippines, Philippines
    PhD Data Partner – Biology – Asia | Fully Remote.Are you ready to use your domain knowledge to advance AI? Join us as a PhD Data Partner and work remotely with flexible hours.We are seeking a highl...Show more
    Last updated: 30+ days ago • Promoted