Remote CDM Position Labcorp – Role at Fortrea (Labcorp), Apply Now
Associate Clinical Data Manager
Locations:
- Bangalore, India
- Remote, India
Time Type: Full-time
Posted On: Posted Today
Time Left to Apply: End Date: December 2, 2024 (10 days left to apply)
Job Requisition ID: 2427808
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Responsibilities/Duties:
- Collaborate and functionally report to Lead DM (LDM) for studies, including:
- Combination of healthy and patient populations.
- Multi-site studies.
- Medium complexity in protocol design or client management requirements.
- Perform all data operational tasks as a lead data reviewer and support the Lead Data Manager. Tasks include but are not limited to:
- Data review and query management to ensure quality standards (both internal and Sponsor) are achieved.
- Ensure that all allocated projects adhere to:
- Relevant protocols.
- Fortrea global harmonized SOPs or client SOPs.
- Specified standards of GCPs.
- Work with the LDM to build study milestone timelines and follow them for on-time deliverables.
- Make suggestions to study timelines based on study design when warranted.
- Assist or lead internal and external Data Management meetings.
- Assist or lead in writing, updating/reviewing, and approving trial data management documentation, including:
- Study-specific case report forms.
- CRF Completion Guidelines.
- Data Management Plan.
- Data Quality Checks (edit checks).
- Keep LDM and internal operational team informed of pertinent project or sponsor-related information, such as:
- Work scope changes.
- Timeline impacts.
- Ensure Data Transfer Agreements are established for all ancillary data vendors.
- Track scope changes and collaborate with the Lead DM to obtain Sponsor approval and process the changes.
- Support the training of new staff on project-specific Data Management processes.
- Ensure service and quality meet specifications outlined in the DMP and scope of work.
- Perform QC on all aspects of work performed in DM Operations to maintain data quality and integrity.
- Provide constructive feedback and initiate process reviews as needed.
- Coordinate with the DM study team to ensure timely receipt and inventory of all data-related information.
- Ensure completion of appropriate documentation and procedures upon project completion.
- Assist or lead the management of the DM study team to achieve client satisfaction through quality data delivery.
- Assist or coordinate internal or external meetings as needed.
- Attend client or internal audits and resolve issues within an appropriate timeframe.
- Address client comments with the study team.
- Assist or provide reports to Sponsors and internal teams as required.
- Assist or lead the completion of Database Lock and Unlock activities with LDM.
- Manage Data Management documentation and administrative tasks, including maintaining the eTMF as required.
- Perform other related duties as assigned by Line Management.
Education/Qualifications:
- University/college degree in life sciences, health sciences, information technology, or related fields preferred.
- Relevant work experience equating to a bachelor’s degree is acceptable in lieu of formal education.
- Fluent in English (written and verbal).
Minimum Requirements:
- 8 to 10 years of Data Management experience.
- Experience handling customer concerns and managing Scope of Work and budgets is preferred.
- Knowledge of clinical trial processes, DM, clinical operations, biometrics, and system applications supporting operations.
- Strong time management skills with the ability to meet project productivity metrics and timelines.
- Ability to work collaboratively in a team environment.
- Good organizational, communication, and interpersonal skills.
- Knowledge of medical terminology.
- Scientific knowledge or a background in science is preferred.
- Teamwork and collaboration skills are essential.
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Keywords: Remote CDM Position Labcorp – Role at Fortrea (Labcorp), Apply Now. Associate Clinical Data Manager, Bangalore India, Clinical Data Management, CRO, Pharmaceutical, Biotechnology, GCP, Data Management, Clinical Trial Process, Health Sciences, Data Review, SOPs, Remote Work. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
