FSP Assoc Manager Clinical Operations (Study Start-Up)

ThermoFisher Scientific; États-Unis; À distance; USD 90 000 - 130 000; Plein temps

Résumé du poste

Thermo Fisher Scientific seeks an Assoc Manager Clinical Ops Study Start-Up to lead a clinical administration team and ensure study start-up excellence across trials. You will coach staff, manage resources, and align training with SOPs while collaborating with senior management on strategic planning.

The role requires a Bachelor's degree, 5+ years in clinical research, and at least 1 year of leadership, with strong knowledge of ICH GCP, budgets, timelines, and risk mitigation.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• 5+ years of clinical research experience including remote and clinical monitoring.
• 1+ year of leadership responsibility.

Responsabilités

• 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.
• 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). Develops and implements training processes for clinical administration and clinical staff, including mentoring of new team members.
• Performs any other duties and projects as assigned by PPD management.

Connaissances

Clinical operations leadership

Study start-up expertise

Leadership and coaching

Budgeting and metrics

ICH GCP knowledge

Communication skills

Formation

Bachelor's degree or equivalent (clinical/research)

Description du poste

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as an Assoc Manager Clinical Ops Study Start-Up - Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our expert team, you'll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As an Assoc Manager Clinical Ops Study Start-Up, 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 You’ll 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

• Bachelor's 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
• 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. You'll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.