Manager, Clinical Operations - Study Start-Up (SSU)

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job Introduction

At Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life-changing medicines to patients. We are seeking a Manager, Clinical Operations- Study Start-Up to join our team. Our Manager, Clinical Operations works toward building a deeper connection and understanding with those who count on us most. Through questioning the status quo and collaborating cross-functionally, the Manager, Clinical Operations provides leadership to a team of Study Start-Up Leaders (SSULs) and ensures the successful performance and delivery of his/her direct report’s project deliverables, on time with high quality. This individual will provide clinical consultation to project teams and will promote new business through participation in project bids and client presentations.

Who we’re looking for:

We are seeking an experienced and proactive Manager for our Clinical Operations team, specializing in study start-up delivery. The ideal candidate will:

• Possess a minimum of 2 years of line management experience in clinical research or a related field.

• Demonstrate exceptional leadership skills to guide and motivate a team of Study Start-Up Leaders (SSULs).

• Excel in time management and prioritization to ensure timely delivery of high-quality start-up activities.

• Have a proven track record of successful clinical trial initiation and management.

• Be adept at problem-solving and adapting to the dynamic environment of clinical research.

• Maintain a patient-centric approach in all aspects of study start-up operations.

Key responsibilities include:

• Overseeing the study start-up process for multiple clinical trials simultaneously

• Mentoring and developing SSULs to enhance team performance

• Collaborating with cross-functional teams to streamline start-up activities

• Implementing best practices to improve efficiency and quality in study initiation across the SSUL team

• Ensuring compliance with regulatory requirements and company SOPs

• Monitoring key performance indicators (KPIs) for study start-up timelines

The successful candidate will join a collaborative team environment and play a crucial role in driving the timely initiation of clinical trials while maintaining the highest standards of quality and keeping the patient at heart.

What you’ll do:

Project Delivery Management and Oversight:

• Consult, facilitate metrics collection and develop action plans with Management/Project Leadership/Leads to keep project on time and within budget.

• Manage and oversee team activities including appropriate resourcing of staff, staff assignments, quality control and efficiency of project deliverables

Performance Management, Staff Development and Talent Management:

• Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan by conducting quality check of deliverables (e.g., on site visits, Central File documentation) and take appropriate remedial action

• Oversee and develop the staff to ensure their performance meets and or exceeds both the business and their own personal goals/objectives through training, mentoring and allocating staff according to their ability

• Motivate and support staff to improve their efficiency and effectiveness at prioritizing work and improving performance evidenced by the work produced, client feedback, audit results and QC measures

• Participate in formal staff review processes e.g., performance and salary reviews to corporate standards and timescales.

Client Management and Business Development:

• Participate in and contribute to Project bids, including client presentations

• Where appropriate, may be responsible to coordinate client or account activities for department or function

General Operations and Functional/Business Unit Management:

• Create a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner

• Maintain a working knowledge of, and ensure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, Parexel SOPs, and where applicable, sponsor SOPs.

General Administration, Manage Personal Competencies and Role Modeling:

• Demonstrate leadership within Clinical department, function or location. This includes taking an active role in departmental, functional or location activities (e.g., management meetings), ensuring employees adhere to corporate policies and following up with management as appropriate.

More about you:

Experience in clinical research with strong understanding & knowledge of clinical trials environment.

• Current or previous line management/leadership experience.

• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or relevant clinical other equivalent experience.

• An honest and ethical work approach to promote the development of life changing treatments for patients.

Why join us:

• Be part of groundbreaking projects that are pushing the boundaries of the industry.

• Experience a collaborative and inclusive work environment that highly appreciates your expertise. Unlock your full potential with professional growth and development opportunities.

• Enjoy work life balance and flexible working hours.

Parexel US Benefits:

• Health, Vision & Dental Insurance Tuition Reimbursement Vacation/Holiday/Sick Time

• Flexible Spending & Health Savings Accounts Work/Life Balance

• 401(k) with Company match Pet Insurance

• Full list of benefits available here: https://www.parexel.com/us-benefits

EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.