Clinical Operations Manager SA - Sponsor Dedicated

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 a wide range of clinical development and technology solutions across more than 20 therapeutic areas. With over 18,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Job Overview:

The Manager is mainly responsible for managing a defined group of locally/centrally/regionally or globally based Site Readiness employees to ensure consistent, timely and high-quality delivery of regulatory, start-up and maintenance activities.

Summary of Responsibilities:

• Partners and collaborates with peers across the organization in order to achieve client-centric delivery in a matrix organization. In particular, collaboration across all stakeholders within Site Readiness.
• Mentors and advises staff in their day-to-day work.
• Assesses staffing and resourcing needs to ensure maximum staff utilization.
• Allocate team members to projects as required, based on experience and availability.
• Interviews, evaluates, and recruits new staff as required while providing recruitment and retention initiatives for existing staff.
• Identifies staff training and development needs and ensures requirements are met.
• Manages employee performance and employee development in a proactive manner.
• Responsible for detailed performance review and management of assigned direct reports, including Annual Performance Management and Development (PMD) and Individual Development Plan (IDP).
• Promotes, reviews, and evaluates quality and performance metrics (individual and/or project specific) and ensures these are adequately documented and communicated.
• Contribute to the development of the group through participating in process improvement initiatives.
• Ensure project deliverables are completed within agreed project specific timelines and in accordance with sponsor expectations and in compliance with SOPs and/or other quality and regulatory requirements.
• Serve as an issue escalation point for concerns either from the external/internal project team members or other staff.
• Participating in client-hosted audits (for completed/active project(s)) and audit responses, attending project specific audits and pre-qualification audits.
• As applicable and assigned by management.
• Provide support to Business Development, including providing information for RFI and RFP responses, and bid defense meetings. Attend bid defense meetings if required.
• Review financial performance of allocated employees (which may include but is not limited to: resource assignment, revenue forecast and recognition, pricing, budgets, and profit margins).
• May provide oversight of transactional clients.
• Coordinate and Lead Project/Country Reviews.
• Where applicable, maintain awareness of current regulatory legislation, guidance and practice related to country delivery. Evaluate the impact of clinical/regulatory changes on business operations and oversee internal regulatory intelligence database updates. May advise on country strategy for project delivery and regulatory strategy.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• University/college degree or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Knowledge of financial control procedures (e.g., costing systems, time reporting).
• Working knowledge of project management/line management processes, preferably regarding study start-up.
• Knowledge of time and cost estimate development.
• Working knowledge of ICH Guidelines and GCP including local and/or international regulatory requirements for the conduct of clinical development programs.
• Broad knowledge of drug development process and client needs.
• Language Skills Required:
• Speaking: Fluent in English.
• Writing/Reading: Fluent in English.

Experience (Minimum Required):

• Five (5) or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO).
• Demonstrated ability to handle multiple competing priorities.
• Ability to utilize resources effectively.
• Financial awareness.
• Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
• Demonstrated ability to lead by example and to encourage team members to seek solutions.
• Experience mentoring junior level staff.
• Good communication, planning and organizational skills.
• Ability to work independently.
• Ability to negotiate and liaise with clients in a professional manner.
• Ability to present to staff at all levels.
• Good computer skills with good working knowledge of a range of computer packages.

Preferred Qualifications Include:

• University/college degree in life science or Master’s or other advanced degree preferred.
• In addition to the minimum required experience, preferably include Three (3) or more years project management/line management responsibility / preferably in Study Start-up.
• PMP or similar certification.
• Working knowledge of Fortrea and the overall structure of the organization.
• Working knowledge of Fortrea sales and business development strategies and procedures.
• Working knowledge of Fortrea SOPs.

Physical Demands/Work Environment:

• Standard office environment/home-based environment.
• Travel Requirements:
• Local, Domestic, Regional, Global.
• less than 10% travel.

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

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com . Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.