Associate Clinical Data Manager

2+ years

Not Disclosed

Bangalore

10 Nov. 8, 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

About Fortrea
Fortrea is a leading global contract research organization (CRO) committed to scientific rigor and clinical development excellence. We provide a comprehensive suite of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, we are transforming the drug and device development landscape for our partners and patients worldwide.

Position Overview

We are seeking a Data Management Lead to oversee the data management (DM) deliverables for clinical studies, including studies involving healthy volunteer and patient populations. The successful candidate will lead multi-site studies, ensure adherence to study timelines, and provide high-quality data management oversight while collaborating closely with project teams to drive project success.

Key Responsibilities

Study Leadership & Project Management

Lead clinical studies with diverse patient populations, managing client relationships, timelines, and deliverables.
Oversee all DM deliverables assigned to your study team, ensuring quality, accuracy, and timeliness in accordance with GCPs and SOPs.
Collaborate with Project Managers to build project timelines, ensuring milestones are met and communicated effectively across study teams.
Lead data-focused project team meetings, working with leads in EDC design, SAS programming, statistics, and PK to ensure all deliverables are coordinated and executed effectively.
Identify potential risks to data management processes and proactively develop mitigation strategies to ensure on-time database lock and project success.
Maintain awareness of other Biometrics functional group deliverables and support cross-functional coordination.
Provide regular updates to Project Managers and stakeholders on project progress, including risks, budget status, and timeline impacts.

Client & Team Relationship Management

Develop and maintain client relationships, responding to client feedback and ensuring satisfaction through regular reviews and proactive issue resolution.
Track scope changes and work closely with the Project Manager to ensure sponsor approval and processing of scope changes.
Act as a mentor and leader within the team, providing guidance and coaching on clinical trial data management processes.
Support performance evaluations for direct reports and provide constructive feedback for career development.

Quality & Compliance

Ensure adherence to relevant clinical trial protocols, global SOPs, and GCP standards.
Perform data reconciliation for clinical databases, safety data, lab data, and other third-party data as required.
Represent Data Management (DM) and Biometrics in new business opportunities and internal audits, ensuring compliance with quality standards and timelines.
Participate in client or internal audits, ensuring that any issues are resolved promptly and client concerns are addressed.

Technology & Process Improvement

Stay informed about emerging DM technologies and process improvements to enhance efficiency at Fortrea.
Contribute to ongoing process improvements within data management practices to drive better outcomes and operational efficiencies.

Qualifications

Education & Experience

University/college degree or equivalent experience in clinical data management or a related field.
At least 6-8 years of experience in data management, with a minimum of 1 year of direct sponsor management experience.
Knowledge of the clinical trial process, biometrics, and related system applications.
Experience handling customer concerns, managing scope of work, and supporting budget management in clinical studies.

Skills

Strong leadership and team management skills with the ability to collaborate cross-functionally.
Exceptional organizational skills with the ability to prioritize tasks and meet project timelines.
Excellent communication skills, both written and verbal, with a customer-focused mindset.
Proficiency in clinical trial management systems (CTMS), eTMF, EDC, and other data management tools.
Ability to manage complex clinical data and perform reconciliations between various systems (e.g., safety, lab, and third-party data).
Knowledge of medical terminology and clinical data management processes.

Why Join Fortrea?

At Fortrea, we are committed to revolutionizing the clinical development process by empowering our teams to bring life-changing therapies to patients faster. As a part of our team, you will have the opportunity to work in a collaborative environment, expand your skills, and make a global impact in clinical research. We value innovation, growth, and a shared commitment to excellence.

Join us at Fortrea, where you will be part of a team that is shaping the future of clinical development and improving patients' lives across the globe.

Equal Opportunity Employer

Fortrea is an Equal Opportunity Employer. We embrace diversity and are committed to an inclusive workforce. We do not tolerate harassment or discrimination of any kind. All employment decisions are based on individual qualifications and business needs. We encourage all individuals to apply, regardless of race, religion, color, national origin, gender, sexual orientation, gender identity, or other legally protected characteristics.