Senior Manager, Clinical Business Administrator

2+ years

Not Disclosed

Remote, USA

10 Oct. 24, 2024

Job Description

Job Type: Full Time Remote 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 dedicated to scientific rigor and has decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, Fortrea is transforming drug and device development for partners and patients globally.

Job Overview

The Senior Manager, Clinical Business Administration (CBA) is responsible for developing and overseeing the implementation of User Access provisioning and Study Builds across clinical platforms. This role is essential for the readiness steps involved in every study launch. With expert knowledge of clinical platforms and studies, the CBA team resolves study issues related to these platforms. Additionally, the Senior Manager will assist in creating CBA training and SOP documentation and ensure effective cross-functional collaboration with project team members, including internal and external vendors.

Summary of Responsibilities

Primary Contact:
Serve as the main point of contact for system administration procedures and project issue escalation across specified applications.
Study Details Management:
Create and update study details in Veeva UCV and Siebel CTMS, including trip report templates.
Documentation:
Maintain CBA job aids and monitor platform inbox for issues and escalations, managing resolutions effectively.
Template Management:
Utilize strong Excel and editing skills for managing templates.
Project Monitoring:
Monitor project schedules and scope to ensure alignment with timelines.
Quality Assurance:
Engage in quality assurance and risk management to meet project deliverables according to Fortrea and client requirements.
Process Improvement:
Initiate enhancements to improve efficiency and quality within the operational team.
Regulatory Compliance:
Ensure all systems and processes comply with applicable regulations and Fortrea requirements.
Procedure Evaluation:
Continuously evaluate the effectiveness of Clinical Business Administrator procedures and adjust processes as needed.
Resource Management:
Establish project resource needs and succession plans for key resources.
Project Plan Implementation:
Implement and monitor progress against project plans, revising as necessary.
Presentations:
Prepare and deliver presentations in collaboration with relevant departments as required.
Project Metrics Management:
Manage and report on project metrics.
Team Leadership:
Lead training, utilization, and performance review of assigned project staff, identifying individual training needs.

Qualifications (Minimum Required)

Education:
University/college degree in life sciences preferred, or certification in a related allied health profession.
Leadership Skills:
Excellent leadership, oral, written, and presentation skills.
Organizational Skills:
Strong planning and organizational abilities, particularly in implementing corporate change.
Interpersonal Skills:
Proven ability to lead by example and foster teamwork.
Clinical Trials Knowledge:
Strong understanding of clinical trials and operations, including study setup and monitoring roles.
Certification:
Veeva Admin certification.
Prioritization:
Ability to handle multiple competing priorities effectively.
Technology Assessment:
Strong ability to understand technology alternatives and their implications for processes.

Experience (Minimum Required)

Supervisory Experience:
Minimum of three (3) years in a supervisory role in a healthcare or clinical research setting.
Relevant Experience:
Eight to twelve (8-12) years of experience in a pharmaceutical company or CRO.
Administration Experience:
Experience with Veeva UCM and Siebel CTMS.
Process Creation:
Proven experience in creating new processes.
Negotiation Skills:
Ability to negotiate professionally with clients.
Financial Knowledge:
Working knowledge of financial control procedures and project management processes.
Regulatory Knowledge:
Familiarity with ICH Guidelines and GCP, including international regulatory requirements for clinical development.

Preferred Qualifications

Advanced Degree:
MBA or equivalent.
Fast-Paced Experience:
Experience in fast-paced environments.
Creative Thinking:
Strong analytical and strategic thinking skills.
Communication Skills:
Excellent communication and interpersonal abilities.
Leadership Qualities:
Strong leadership capabilities.

#LI-REMOTE
#LI-GS1

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. We are committed to revolutionizing the development process to ensure the swift delivery of life-changing therapies to patients in need. Join our exceptional team and embrace a collaborative workspace that nurtures personal growth, enabling you to make a meaningful global impact.

Equal Opportunity Employer
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. We encourage all qualified individuals to apply.

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

Visit Fortrea's website for more details.