Senior Clinical Data Manager

2+ years

Not Disclosed

Bangalore

10 Sept. 5, 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 Description: Senior Clinical Data Manager

Company Overview:

Fortrea is a leading global Contract Research Organization (CRO) with a deep-rooted passion for scientific rigor and decades of experience in clinical development. We offer a broad spectrum of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff members operating in more than 90 countries, Fortrea is dedicated to transforming drug and device development for partners and patients worldwide.

Position Overview:

As a Senior Clinical Data Manager at Fortrea, you will work closely with the leadership team to provide guidance, mentorship, and training to the Data Management (DM) team, ensuring the highest standards of practice are maintained. You will lead complex studies involving diverse patient populations, manage multi-site projects, and maintain robust client relationships. Your role will require effective organization, prioritization, and the ability to handle reduced timelines and strong client management needs.

Summary of Responsibilities:

Study Leadership:
- Lead studies with complex protocols, including those involving healthy volunteers and patient populations.
- Ensure all DM deliverables meet established timelines, providing direction and reviewing output to ensure the highest quality.
Project Management:
- Develop and oversee study timelines in collaboration with Project Managers or FSP Leads.
- Provide leadership to DM project teams, coordinating with EDC Design, SAS Programming, Statistics, and PK to ensure all deliverables are on track.
- Proactively identify risks and communicate data-driven solutions to achieve database lock dates.
Compliance and Quality Assurance:
- Ensure adherence to relevant protocols, global SOPs, and GCP standards.
- Maintain awareness of Biometrics functional group deliverables and support risk mitigation strategies.
- Manage the receipt, inventory, and documentation of all data-related information from clinical sites and vendors.
Client and Team Management:
- Develop and maintain client relationships, reviewing client satisfaction and implementing action plans for improvement.
- Track scope changes, ensure sponsor approval, and manage the scope change process.
- Provide mentorship and coaching to DM team members, supporting their professional development and performance evaluations.
Process Improvement and Technology:
- Stay updated with new DM technologies and industry-wide advancements.
- Contribute to the writing, reviewing, and updating of SOPs and related documents.
- Perform data reconciliation and utilize local systems for batch data loads as needed.
Representation and Audits:
- Represent DM in new business opportunities and bid defense meetings, offering innovative solutions to meet client needs.
- Attend and address issues in client or internal audits, resolving comments with the study team.

Experience and Qualifications:

Experience:
- Minimum of 8 years in clinical data management, including at least 2 years in direct sponsor management and 2 years of technical mentoring experience.
- Proven track record in managing Scope of Work and budgets, customer negotiations, and leading by example on project strategies.
Knowledge:
- Comprehensive understanding of the clinical trial process, data management, clinical operations, and system applications.
- Familiarity with CRO industry relationships and regulatory obligations.
Skills:
- Excellent time management, organizational, and communication skills.
- Ability to mentor junior team members and provide subject matter expertise on DM practices.
- Strong problem-solving attitude and ability to work effectively in a team environment.

About Fortrea:

At Fortrea, we are committed to revolutionizing the clinical development process and delivering life-changing therapies to patients. We value diversity and inclusion and are proud to be an Equal Opportunity Employer. We encourage motivated problem-solvers and creative thinkers to join our collaborative workspace and make a global impact.

For more information about Fortrea and to explore career opportunities, visit www.fortrea.com.

Equal Opportunity Employer Statement:

Fortrea is dedicated to creating a diverse and inclusive workforce. We do not tolerate harassment or discrimination of any kind and make employment decisions based on business needs and individual qualifications. We encourage all qualified individuals to apply. For details on how we collect and store your personal data, please refer to our Privacy Statement.

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Senior Clinical Data Manager

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