Senior Clinical Data Manager

2-8 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: Pioneering Clinical Development Worldwide

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. With over 19,000 staff operating in more than 90 countries, Fortrea is transforming drug and device development for partners and patients around the world.

Key Responsibilities

Study Leadership: Lead studies involving healthy volunteer and patient populations, multi-site, complex protocol design, and strong client management or reduced timelines. Effectively organize and prioritize workload and deliverables.
Project Accountability: As the Study Manager, ensure all DM deliverables are met according to established timelines. Provide guidance to DM study teams and review their output to maintain high quality while adjusting resource allocations as needed.
Protocol Adherence: Ensure all projects comply with relevant protocols, global harmonized SOPs, and GCP standards.
Timeline Management: Collaborate with Project Managers or FSP Leads to build timelines that meet contracted milestones, facilitating communication across disciplines and the project team.
Team Leadership: Provide leadership and accountability to DM project teams. Lead data-focused internal project team meetings and coordinate with EDC Design, SAS Programming, Statistics, and PK leads to ensure all deliverables are planned and coordinated. Identify potential risks/mitigations and communicate effectively to achieve database lock dates.
Interdepartmental Awareness: Maintain awareness of other Biometrics functional group deliverables to support risk and mitigation strategies. Consult with Project Managers and/or functional group management as necessary.
Client Communication: Keep Project Managers, Biometrics management, and/or sponsor services informed of project progress, budget status, work scope changes, and timeline impacts.
Data Management: Coordinate receipt and inventory of all data-related information from clinical sites and vendors. Ensure proper documentation and procedures are followed upon project completion.
Client Relationships: Develop and maintain client relationships, review client satisfaction surveys, and implement action plans to drive process improvements and team training.
Scope Management: Track scope changes and work with Project Managers to ensure Sponsor approval and scope change processing.
Mentorship: Provide leadership, mentorship, and coaching in DM-related clinical trial processes, department technical capabilities, and turnaround durations to the internal study team.
Performance Evaluation: Support DM supervisors and managers in evaluating team members, providing constructive feedback to aid in career development and competency standards achievement.
Technology and Process Improvement: Stay updated with new DM technologies and industry-wide technology to improve processes at Fortrea.
Quality Assurance: Ensure service and quality meet agreed-upon specifications per the DMP and scope of work. Contribute to writing, reviewing, and updating SOPs and associated documents.
Record Maintenance: Maintain accurate records of all work undertaken.
Data Reconciliation: Perform reconciliation of the clinical database against safety data, laboratory data, or other third-party data as appropriate.
Business Development: Represent DM and Biometrics in new business opportunities and actively promote Biometrics services to sponsors.
Audit Support: Attend and action client or internal audits and resolve issues promptly. Address client comments with the study team.
Strategy Development: Work with the management team to develop and implement directional strategies, providing technical input and rolling out training/mentorship to DM staff.
Additional Duties: Perform other related duties as assigned by management.

Experience and Qualifications

Education: University/college degree in life sciences, health sciences, information technology, or related fields. Equivalent work experience will be accepted in lieu of a degree.
Experience: 8 years of combined early or late-stage DM experience, including a minimum of 2 years of direct sponsor management and at least 2 years of technical mentoring. Proven experience in customer negotiations and managing Scope of Work and budgets.
Skills: Thorough knowledge of clinical trial processes, DM, clinical operations, biometrics, and system applications to support operations. Proven ability to lead project strategies, achieve department goals, and encourage team members to find solutions. Strong time management skills and ability to meet project productivity metrics and timelines.
Teamwork and Mentorship: Ability to work collaboratively in a team environment and mentor junior department members, providing SME guidance on DM practices. Experience representing DM in bid defense meetings and providing innovative client solutions.
Communication and Problem-Solving: Good organizational, communication, and interpersonal skills. Constructive problem-solving attitude under deadline pressure, incomplete information, or unexpected events.

Why Join Fortrea?

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment to revolutionizing the development process ensures the swift delivery of life-changing 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.

Equal Opportunity Employment

Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on the needs of our business and the qualifications of the individual. We do not discriminate based on race, religion, color, national origin, gender (including pregnancy or medical conditions/needs), family or parental status, marital status, sexual orientation, gender identity, gender expression, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

Join Fortrea and make a difference in global healthcare.

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