Manager, Cdm

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), dedicated to advancing clinical development and transforming drug and device solutions across more than 20 therapeutic areas. We partner with pharmaceutical, biotechnology, and medical device companies to drive excellence in clinical trials, ensuring a swift delivery of life-changing therapies to patients worldwide. With operations spanning 90+ countries, Fortrea is at the forefront of improving patient outcomes and revolutionizing the clinical trial process.

Role Overview

We are seeking a Global Data Management Supervisor to manage a team responsible for executing critical data management functions. This includes user account management, eTMF documentation, data entry, and decommissioning activities. The Global Data Management Supervisor will be responsible for achieving performance targets, supervising staff, ensuring data quality, and collaborating with stakeholders to meet and exceed business goals.

Key Responsibilities

Resource Management: Oversee resource allocation based on forecast models to ensure business Service Level Agreements (SLAs) are met or exceeded.
Staff Supervision & Development: Supervise, mentor, and evaluate staff performance. Support career development, people skills, and competency achievement for global staff.
Data Management Oversight: Manage eTMF documentation tasks, data entry activities, and user account management (activations, deactivations, modifications) to ensure smooth data management operations.
Quality Assurance: Support the execution of Global Data Management Plans and Quality Management Plans. Ensure staff deliver accurate, consistent, and timely clinical data.
Project Support: Assist locally based project teams to ensure client satisfaction (internal and external) through timely, on-budget, and quality data delivery.
Training & Development: Assist in the development of training programs and ensure staff meet competency requirements for their roles.
Process Improvement: Identify and implement process improvements to enhance operational performance and support revenue and margin targets.
Client & Business Development Support: Create action plans to address performance issues and provide support to Business Development in developing time and cost estimates.
Staff Utilization & Billability: Oversee utilization and billability of team members, managing resource planning and recruitment based on skill sets, competencies, and availability.
Documentation: Contribute to the development of global SOPs and procedures related to data management, user account management, and eTMF processes.
Staff Performance Reviews: Ensure that employee performance reviews, training, and development plans are completed in accordance with Fortrea guidelines.
Additional Duties: Other duties as needed or assigned.

Experience & Qualifications

Minimum Required:

8 to 10 years of relevant work experience, including 2 to 4 years of supervisory experience.
Experience managing teams of 10 to 15 employees within one region (e.g., Asia Pacific, Europe, North America).
Strong knowledge of user account management, data entry activities, and eTMF documentation.
Experience with clinical data management across multiple therapeutic areas.

Preferred:

Bachelor’s degree in a relevant field, or equivalent experience.
Proven ability to drive results through effective team management, staff development, and quality control.
Strong interpersonal and leadership skills with the ability to collaborate across departments and geographies.

Why Join Fortrea?

At Fortrea, we are looking for problem-solvers and creative thinkers who share our passion for overcoming challenges in clinical trials. By joining our team, you will contribute to the rapid development of life-changing therapies, work in a collaborative environment, and have ample opportunities for personal and professional growth.

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

Equal Opportunity Employer

Fortrea is an Equal Opportunity Employer and strives for diversity and inclusion within the workforce. We do not tolerate harassment or discrimination of any kind and make employment decisions based on business needs and individual qualifications. We encourage individuals from all backgrounds to apply.

Fortrea is an EOE/AA employer, and we do not discriminate based on race, religion, color, national origin, gender, age, sexual orientation, disability, veteran status, genetic information, or any other legally protected characteristic.

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Manager, Cdm

Job Description

Role Overview

Key Responsibilities

Experience & Qualifications

Why Join Fortrea?

Equal Opportunity Employer

Privacy Statement

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