Associate Clinical Data Manager

6-8 years

Not Disclosed

Bangalore

10 Aug. 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, 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

Join Fortrea: Leading Innovation in Clinical Development

As a global leader in contract research organizations (CROs), Fortrea is committed to scientific excellence with decades of experience in clinical development. We provide a broad range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff in over 90 countries, we are at the forefront of transforming drug and device development for our partners and patients worldwide.

Position Overview

Role: Data Manager
Location: [Specify Location]
Reports To: [Specify Supervisor]

Summary of Responsibilities

Study Leadership: Oversee studies involving healthy volunteers, patient populations, and multi-site protocols. Manage client relationships, prioritize workload, and meet timelines efficiently.
Accountability: Ensure all data management (DM) deliverables meet established timelines and quality standards. Provide guidance and review outputs of the DM study team.
Protocol Compliance: Ensure projects adhere to protocols, global SOPs, and GCP standards.
Timeline Management: Collaborate with Project Managers to develop and maintain timelines that align with contracted milestones. Communicate with leads across disciplines and the full project team as needed.
Team Leadership: Lead DM project teams, conduct internal meetings, and coordinate with EDC Design, SAS Programming, Statistics, and PK teams. Identify and address potential risks and ensure database lock dates are met.
Risk Management: Stay aware of other Biometrics functional group deliverables to support risk mitigation strategies. Consult with Project Managers and functional group management as needed.
Communication: Keep Project Managers, Biometrics management teams, and sponsor services informed about project updates, including budget status and scope changes.
Client Relations: Develop and maintain client relationships, review satisfaction surveys, and address feedback.
Scope Management: Track and process scope changes, ensuring sponsor approval.
Mentorship: Provide leadership, mentorship, and coaching in DM processes. Support performance evaluations and career development for team members.
Technology: Stay current with new DM technologies and industry trends. Maintain accurate records and reconcile clinical databases with safety and laboratory data.
Business Development: Represent DM and Biometrics in new business opportunities. Attend and resolve issues from client or internal audits.
Promotion: Actively promote Biometrics services to sponsors.

Required Experience

Experience: 6 to 8 years of data management experience, including at least 1 year of direct sponsor management. Experience in handling customer concerns and managing Scope of Work and budgets is preferred.
Knowledge: Proficiency in the clinical trial process, data management, clinical operations, biometrics, and relevant systems. Familiarity with medical terminology is beneficial.
Skills: Strong organizational, communication, and interpersonal skills. Ability to manage time effectively, collaborate with teams, and adhere to productivity metrics and timelines.

Qualifications

Education: University/college degree or equivalent relevant experience. Experience and/or education equivalent to a bachelor's degree will be considered in lieu of formal educational requirements.
Language: Fluent in English, both written and verbal.

Why Fortrea?

At Fortrea, we are looking for motivated problem-solvers and creative thinkers who are passionate about overcoming barriers in clinical trials. Our commitment to revolutionizing the development process enables the swift delivery of life-changing therapies. Join us and be part of a collaborative environment that supports personal growth and global impact.

For more information about Fortrea, visit www.fortrea.com.

Equal Opportunity Employment

Fortrea is an Equal Opportunity Employer. We value diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender, family status, marital status, sexual orientation, gender identity, age, veteran status, disability, or any other legally protected characteristic. We encourage all to apply.

For details on how we collect and store your personal data, please refer to our Privacy Statement.

Be a part of Fortrea's mission to transform global healthcare. Apply today!

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Associate Clinical Data Manager

Job Description

Join Fortrea: Leading Innovation in Clinical Development

Position Overview

Summary of Responsibilities

Required Experience

Qualifications

Why Fortrea?

Equal Opportunity Employment

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