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

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 world´s 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, you´ll be involved with the latest medical technologies and treatments, witnessing their development firsthand. When the drug you worked with gets approved, you know you´ll touch many patient´s 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.

• practices.

• 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 ERG’s (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.