Sr. Manager, Clinical Operations / Madison, WI (On-Site)

*** Experience working in a management/leadership role within a CRO (Clinical Research Organization) and understanding of GCP (Good Clinical Practices) is strongly preferred ***

Ensure you read the information regarding this opportunity thoroughly before making an application.

As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US.

We are currently seeking a Sr. Manager, Clinical Operations, to interact directly with our healthy volunteer participants while learning to read clinical research protocols and enjoy working in a fast-paced team-oriented environment. Each day is different, you will be exposed to a wide variety of Therapeutic Indications and study types (ascending dose, first-in-human, food effect, drug to drug interactions, etc.)

This is a full-time, office/clinic-based job in Madison, WI .

If you join us, you will work with some of the worlds leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug.

Many are drawn to this profession because of its direct impact on patient care. If this is your case, you will not miss that working in Phase 1 trials. Whilst allowing you to have a close face-to-face relationship with participants, and as you continue to practice your clinical skills and knowledge, youll be involved with the latest medical technologies and treatments, witnessing their development firsthand. When the drug you worked with gets approved, you know youll touch many patients lives around the world.

WHAT YOU WILL DO:

Responsible for management, administration, organization and conduct of the Study Operations department. Provides leadership, training, coaching and mentoring of clinical operations staff.

Other key responsibilities :

• Directly or indirectly supervise clinical operations technical and professional staff.

• Manage the scheduling of resource requirements for all teams under their remit ensuring staff are utilized as efficiently as possible and ensure the safety of volunteers at all times.

• If scope includes overseeing the Processing Laboratory: Manage the Processing Laboratory and sample dispatch process, ensuring staff are utilized as efficiently as possible and ensuring client requirements are delivered accurately and on time.

• Initiate and coordinate the ongoing review of business processes to establish a culture of innovation and improvement.

• Assist the Senior Clinic Director to compile and implement the Annual P&L for the business unit.

• Manage the annual business unit capital budget and capital expenditure request (CER) process.

• Understand and ensure regulatory compliance for functional areas of responsibility.

• Support the Senior Clinic Director in the communication of the Fortrea vision to all staff by articulating the goals and objectives of the company in the appropriate format.

• Responsible for the facilities services on the site through effective management of the outsourced providers, ensuring the contractors provide a flexible service that meets the needs of the business within the budgeted guideline set.

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• Manages the security of buildings, staff and visitors in line with Fortrea policy. Responsible for the coordination, communication escalation of any security issues that arise.

• Full responsibility for managing all direct reports including hiring, employee development and performance reviews, determining pay and promotions and departmental succession planning

  • 10-15 Direct reports

  • 5-15 Indirect reports

• All other duties as needed or assigned.

YOU NEED TO BRING...

• Degree in Business management or equivalent

• Five (5) years in clinical research environment with proven management responsibility

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements

The important thing for us is you are comfortable working in an environment that is:

• Fast paced : where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.

• Changing priorities constantly asking you to prioritize and adapt on the spot.

• Teamwork and people skills are essential for the study to run smoothly.

• Technology based . We collect our data directly into an electronic environment.

What do you get?

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)

• 401(K)

• Paid time off (PTO)

• Employee recognition awards

• Multiple ERGs (employee resource groups)

Physical Requirements:

• Ability to work in an upright and /or stationary position for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.

• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Regular and consistent attendance.

• Varied hours may be required. xywuqvp

Learn more about our EEO & Accommodations request here.