Clinical Operations Manager I
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 Clinical Operations Manager, 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.
Ensure that all work is carried out in strict adherence with relevant protocols, SOP’s, and in compliance with ICH/GCP guidelines.
Ensure that Operations staff is trained and compliant with SOP’s and Skills checks. Ensure that all training files are up to date and complete in accordance with SOPs and ICH/GCP.
Ensure that the scientific and medical standards provided are met.
Assist client services with developing client proposals and attend client meetings as needed.
Assist client services with client visits and interactions as appropriate.
Initiates collaborative relationships with external institutions when protocol is required.
Initiates procurement of external resources, consultants, or equipment when protocol is required.
Develops strategies for efficient study conduct, data collection, subject management and safety monitoring. Coordinates efforts interdepartmentally to accomplish these strategies.
Champion/drive implementation of new company initiatives in terms of process improvement or new technology related to clinical research.
Supports management in ensuring professionalism and adherence to company principles of Customer Service.
Demonstrate ability to lead by example and to encourage team members to seek solutions.
Ensure that the safety, welfare and dignity of subjects are not compromised.
Ensure that the staff is adequately trained to meet the quality standards and forecastworkload.
Ensure that the clinical staff maintains the highest levels of client service to both internal and external clients at all times.
Ensure that a safe working environment is maintained and that safe working practices are employed.
Assist with the development of Operation’s department budget.
Responsible for all aspects of project related matters in agreement with client and supervisory personnel.
Make recommendations for timing, logistics, and feasibility for proposed studies.
Meet the overall schedule agreement with the client.
Ensure that appropriate cost monitoring systems are in place and that accurate project accountability is maintained.
Sets standards, policies, and guidelines for the efficient management of clinical operations.
Instill in all team members the Company’s commitment to quality and meeting the client’s requirement without error, on time, every time.
Ensure that full and accurate data records are maintained.
Performs supervisory duties including but not limited to interviewing, hiring, training, intervention, discipline, and discharge of operations staff.
Coaches and mentor's staff. Initiates, plans and implements appropriate staff development programs.
Continuously seeks out new and better ideas, driving best practices.
All other duties as needed or assigned.
Mandatory immunizations and screening as required.
Handling of biologically hazardous and radiolabeled material is necessary.
Must be able to see (distinguish colors) and hear to meet, if necessary, the job requirements.
Must have excellent command of the English language, both oral and written.
Must be able to use hands to finger, handle, or touch objects, tools or controls, including a computer keyboard, for up to 6 hours per day.
Must be able to stand and/or bend for up to 6 hours per day.
Overtime and weekend work as required.
All other duties as needed or assigned.
YOU NEED TO BRING…
BS in science or medical field. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
6-8 years clinical research experience. Minimum of 5 years supervisory experience or 4-5 years of progressive and proven leadership responsibilities in clinical research coordination/management.
Six Sigma Green Belt is preferred.
Travel Requirements: less than 5% of the time for potential cross-site support needs or external training needs.
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)
Learn more about our EEO & Accommodations request here.