Clinical Operations Manager FSP

Work Schedule

Environmental Conditions

Job Description

Join Us as a Manager Clinical Admin Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

As part of our expert team youll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Manager Clinical Admin you will oversee the daily line management responsibilities of your assigned team. You will serve as a positive leadership and professional role model for all clinical administration staff providing direct coaching and development support to your operational teams. You will be ultimately responsible for effective resourcing alignment training and ongoing professional and technical development for all clinical administration staff. You will collaborate with clinical operations senior management and executive staff on strategic planning and business development as required. Your primary focus will be on the line and performance management of team members. You will act as a point-of-escalation regarding performance concerns and training needs to ensure adherence to PPD SOPs and WPDs. Additionally you will work in collaboration with the leadership team for resourcing needs.

What Youll Do:
Leads the day-to-day management of multiple clinical administration team members providing direct coaching and development support to assigned staff. Oversees resourcing alignment training and on-going professional development for assigned division or office. Ensures all Clinical Administration initiatives are implemented to ensure efficiency in proposed processes consistency in execution and quality output
Analyzes performance metrics and provide feedback to team as appropriate to enhance individual and team performance
Develops and implements Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs) as necessary. Develops and implements training processes for clinical administration and clinical staff. Implements project specific training activities for research staff including mentoring of new team members including other Clinical Managers
Performs any other duties and projects as assigned by PPD management


Education and Experience Requirements:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Significant clinical research experience (comparable to 5 years) including remote and clinical monitoring and experience in all phases of study life cycle including start up interim and close out.
1 year of leadership responsibility
In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills and Abilities:
Advanced knowledge of ICH GCP applicable regulations and PPD/Client procedural documents

Extensive experience in TMF management or clinical operations within clinical research industry

Proficiency in electronic TMF systems and document and data management tools with a focus on audit readiness
Advanced knowledge in all phases of clinical trials specifically study start-up study maintenance and study close-out
Advanced skills in managing motivating and mentoring staff
Ability to analyze and manage clinical administration portion of Business Development bids and contracts for multiple studies within specific division(s)/office(s)
Strong knowledge of budgets projects and metrics
Ability to handle multiple tasks simultaneously to meet rigorous timelines and to work effectively in stressful situations
Excellent organization skills and strong attention to detail
Excellent communication and interpersonal skills
Ability to travel if required


Working Conditions and Environment:
Work is performed in an office and/or a clinical environment with exposure to electrical office equipment.
Exposure to biological fluids with potential exposure to infectious organisms.
Travel varies (more for some individuals) which includes frequent drives to site locations and domestic travel and rare international travel where applicable
Personal protective equipment required such as protective eyewear garments and gloves in some instances.
Exposure to fluctuating and/or extreme temperatures on rare occasions

Why Join Us

When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.