Senior Clinical Data Manager

Fortrea

2+ years

Not Disclosed

Bangalore

10 Nov. 6, 2024

Job Description

Job Type: Full Time Remote 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 Opportunity: Study Manager at Fortrea

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 with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

We are currently seeking an experienced Study Manager to lead and oversee the planning, execution, and successful completion of clinical data management (DM) deliverables. The ideal candidate will have a proven track record in managing clinical trial studies, including working with complex protocols, diverse patient populations, and multi-site clinical trials. The Study Manager will work closely with internal teams and clients to ensure project deliverables are met on time, and within scope and budget.

Key Responsibilities:

Study Leadership: Oversee studies with complex designs, including healthy volunteer and patient populations, and multi-site clinical trials. Lead the DM study team, ensuring all deliverables meet established timelines and quality standards.
Project Planning & Coordination: Work with the Project Manager or FSP Lead to develop study timelines, ensure milestones are met, and communicate with study leads across EDC Design, SAS Programming, Statistics, and PK.
Team Management & Accountability: Provide leadership and guidance to the internal project team, ensuring high-quality output and adjusting resources as necessary to meet deadlines.
Risk Management: Proactively identify project risks and implement mitigation strategies to ensure database lock dates are achieved.
Cross-functional Collaboration: Collaborate with the Biometrics functional groups, sponsor services, and other departments to ensure smooth coordination and alignment on study progress.
Client Relationship Management: Maintain and build strong relationships with clients, addressing client concerns and ensuring satisfaction with project progress. Implement action plans based on client feedback.
Scope & Budget Management: Track scope changes, ensure sponsor approval, and work with the Project Manager or FSP Lead to manage scope changes and budget adjustments.
Training & Development: Provide mentorship and coaching to junior team members, fostering their professional development in clinical trial processes and DM capabilities.
Regulatory & Compliance: Ensure all studies adhere to relevant protocols, SOPs, and GCP standards. Participate in audits and address client comments or findings.
Business Development: Represent DM services in new business opportunities, and actively contribute to bid defenses and solution development.
Data Reconciliation: Oversee the reconciliation of clinical databases with safety data, lab data, or other third-party data as appropriate.

Required Experience & Skills:

Experience: 8+ years of experience in data management (DM) in clinical trials, with a minimum of 2 years of direct sponsor management experience, and at least 2 years of mentoring experience.
Clinical Trial Expertise: In-depth knowledge of the clinical trial process, DM, clinical operations, biometrics, and system applications.
Leadership & Mentoring: Proven ability to lead cross-functional teams, mentor junior staff, and foster a culture of collaboration and solution-driven approaches.
Client Management: Experience handling customer negotiations, managing scope of work (SOW), and budget management.
Time Management: Strong ability to manage time effectively, prioritize tasks, and meet deadlines in a high-pressure environment.
Communication Skills: Excellent organizational, communication, and interpersonal skills, with a constructive, problem-solving attitude.
Regulatory Knowledge: Understanding of the regulatory obligations of CROs and pharmaceutical/biotech companies.
Business Development: Experience representing DM in bid defense meetings and contributing to the acquisition of new business.

Education:

Bachelor’s/Master’s degree in Life Sciences or a related field.

Location: Bangalore, India

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer. As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual, without discrimination on the basis of race, religion, gender, disability, veteran status, sexual orientation, gender identity, or any other legally protected characteristic.

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Senior Clinical Data Manager

Job Description

Job Opportunity: Study Manager at Fortrea

Key Responsibilities:

Required Experience & Skills:

Education:

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