Mgr Centralized St Op

8+ 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
As a leading global contract research organization (CRO), Fortrea is committed to scientific rigor and decades of experience in clinical development. We provide pharmaceutical, biotechnology, and medical device clients with innovative solutions across 20+ therapeutic areas. Operating in 90+ countries, Fortrea transforms drug and device development, enabling the swift delivery of life-saving therapies to patients globally.

Position Overview

Fortrea is seeking a Manager, Clinical Operations and Quality Oversight to lead, manage, and oversee the performance and development of a team of direct reports within the department. This role will ensure quality and regulatory compliance, support ongoing training efforts, and oversee performance management, resource allocation, and financial oversight. The ideal candidate will have extensive experience in clinical operations, GCP compliance, and quality oversight, with a strong focus on training, productivity, and financial management.

Key Responsibilities

Staff Management and Development

Supervise and manage the performance of assigned direct reports within the department, including conducting performance reviews, setting goals, and creating development plans.
Lead annual Performance Management & Development (PMD) and Individual Development Plan (IDP) processes for direct reports.
Address performance issues and resolve employee relations matters in coordination with HR and management.
Conduct training assessments and assist in implementing global training and development efforts.
Foster positive relationships with relevant stakeholders to ensure business growth opportunities and client satisfaction.

GCP & Quality Oversight

Ensure direct reports are compliant with Good Clinical Practice (GCP) training and standards, overseeing GCP implementation within the team.
Identify and address GCP and quality issues through regular interactions with direct reports.
Monitor training compliance and ensure up-to-date training records and adherence to training matrices.
Provide input on Standard Operating Procedures (SOPs) and quality management templates used by project management and clinical operations staff.
Support the onboarding and role-specific training for new hires, ensuring they meet GCP and quality standards.
Hold staff accountable for quality, compliance, and adherence to client SOPs and timelines.

Productivity and Financial Management

Review workload metrics and report progress on assigned tasks, ensuring alignment with budget goals.
Track and manage billable hours and utilization rates for direct reports, escalating discrepancies and developing mitigation strategies.
Collaborate in resource management and assist with recruitment, including screening and interviewing candidates.
Monitor financial management, ensuring that expenses comply with travel and home-based policies.
Lead Six Sigma and process improvement initiatives to enhance operational efficiency and quality.
Oversee the budgeting process, ensuring team deliverables are in line with financial targets.

Cross-Functional Leadership

Represent the department in cross-functional initiatives and work with leadership teams to implement management strategies, policies, and procedures.
Coach and guide staff on maintaining effective relationships with key stakeholders across the organization.

Qualifications

Experience:

8+ years in clinical operations, with at least 2-4 years in a supervisory role.
Demonstrated experience managing clinical operations teams, overseeing performance, and driving quality oversight and GCP compliance.
Proven track record in resource management, training development, and process improvements.
Strong experience in financial management, including budgeting, expense management, and metrics reporting.
Familiarity with Six Sigma or similar process improvement methodologies is preferred.

Education:

Bachelor’s degree in a related field (e.g., Life Sciences, Healthcare, or Business).
Postgraduate degree (e.g., MSC or equivalent) in clinical, science, or management-related disciplines is a plus.
Relevant certifications (e.g., GCP, Clinical Research) are advantageous.

Why Join Fortrea?

At Fortrea, we believe in innovation, collaboration, and personal growth. We are committed to providing an inclusive and supportive environment where you can thrive professionally while contributing to the development of life-changing therapies. Join us and be part of a team that is redefining the future of clinical trials and patient access.

For more information about Fortrea and to explore other career opportunities, visit www.fortrea.com.

Equal Opportunity Employer

Fortrea is an Equal Opportunity Employer. We are dedicated to creating a diverse, inclusive workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on the qualifications of the individual and the needs of our business.

Fortrea is an EOE/AA employer, welcoming applicants from all backgrounds to apply. We make hiring decisions based on merit and qualifications, without regard to race, religion, color, national origin, gender, age, disability, or other legally protected characteristics.