Associate Clinical Data Manager

2+ years

Not Disclosed

Bangalore

10 Nov. 6, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Data Management (DM) Lead
Company: Fortrea
Location: Remote
#LI-Remote

About Fortrea:

Fortrea is a global leader in clinical development, offering a broad range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a team of over 19,000 professionals operating in more than 90 countries, we are dedicated to advancing drug and device development and improving patient outcomes worldwide.

Position Overview:

As a Clinical Data Management (DM) Lead at Fortrea, you will oversee the full data management lifecycle of clinical trials, ensuring timely, high-quality delivery of clinical data. You will be responsible for leading multi-site studies, managing client relationships, and collaborating with cross-functional teams to ensure seamless execution. Your leadership will be critical in meeting project timelines and maintaining the highest standards of data quality while fostering strong team collaboration.

Key Responsibilities:

Study Leadership: Lead data management aspects of clinical trials, including studies involving healthy volunteers and patient populations. Ensure effective prioritization of workloads and adherence to deadlines.
Project Delivery: Accountable for all Data Management deliverables, providing guidance to the DM study team to meet established timelines. Review study team outputs to ensure high quality and adjust resource allocations as necessary.
Compliance & Standards: Ensure that all allocated projects are executed in compliance with relevant protocols, global SOPs, and GCP standards.
Timeline Management: Collaborate with Project Managers to develop timelines that align with contracted milestones, and actively manage project deliverables.
Team Leadership: Provide leadership and accountability to the DM project team. Lead internal meetings, identify potential risks, and ensure proactive communication to achieve key milestones, such as database lock dates.
Risk Mitigation: Work with cross-functional leads (e.g., EDC Design, SAS Programming, Statistics, PK) to identify risks and mitigation strategies that could impact timelines, resources, and deliverables.
Client Relations: Build and maintain strong relationships with clients, review client satisfaction surveys, and address any concerns regarding project progress or deliverables.
Scope Management: Track scope changes, ensure sponsor approval is obtained for any changes, and ensure accurate processing of scope adjustments.
Mentorship: Provide mentorship and coaching to DM team members on clinical trial processes, data management practices, and career development.
Technology & Process Improvement: Stay updated on new data management technologies and industry trends. Implement process improvements to enhance operational efficiency at Fortrea.
Database Reconciliation: Reconcile clinical databases with safety, laboratory, or third-party data to ensure data accuracy and completeness.
Business Development: Represent DM in new business opportunities, promoting the capabilities of Fortrea’s biometrics services to potential clients.
Audit & Compliance: Participate in audits and ensure that all audit findings are addressed within specified timelines.

Qualifications:

Education & Experience:

Required:
- University/College degree (or equivalent experience).
- Minimum of 6 to 8 years of experience in Data Management (DM), with at least 1 year in direct sponsor management.
- Familiarity with managing Scope of Work (SOW) and budgets.
- In-depth knowledge of clinical trial processes, DM, clinical operations, biometrics, and relevant system applications.
Preferred:
- Experience in client relationship management and handling customer concerns.
- Knowledge of medical terminology and GCP.

Skills & Competencies:

Leadership: Proven ability to lead and mentor teams, and collaborate across cross-functional departments.
Project Management: Strong organizational and time management skills; ability to prioritize and adhere to deadlines.
Communication: Excellent oral and written communication skills; effective at managing client interactions and internal team communications.
Problem-Solving: Ability to identify risks, propose mitigations, and make data-driven decisions to ensure project success.
Technical Proficiency: Proficient in clinical data management tools and technologies, with experience in database management, clinical trial management systems (CTMS), and relevant software.

What You Will Get:

Competitive Salary & Benefits:
- Comprehensive healthcare coverage
- 401(k) plan with company match
- Paid time off and flexible work options
- Employee Stock Purchase Plan (ESPP)
- Performance-based incentives

Why Fortrea?

At Fortrea, we’re driven by the desire to transform drug and device development, making a positive impact on the lives of patients worldwide. As a Clinical Data Management (DM) Lead, you will play a key role in ensuring the successful execution of clinical trials and helping shape the future of global healthcare. We foster a collaborative environment where you can grow professionally and personally, and have the opportunity to make a meaningful difference in the industry.

Fortrea is an Equal Opportunity Employer:
We are committed to a diverse and inclusive workforce and do not tolerate harassment or discrimination. We make employment decisions based on individual qualifications and the needs of the business.

Application Deadline:
Applications will be accepted on a rolling basis until the position is filled.

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