Clinical Operations Manager II

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 Manager, Clinical Operations II, 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 the supervision of assigned direct reports within PI MS. Responsible for detailed performance review and management of assigned direct reports including Annual Performance Management and Development (PMD) and Individual Development Plan (IDP). Responsible for appropriate management and resolution of performance issues. Effectively communicate management strategies, policies, and procedures in conjunction with leadership teams. Develop and maintain effective relationships with the management team to manage assigned staff in a matrix environment. Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business.

Other key responsibilities:

• Has regulatory oversight of direct reports by ensuring regulatory training is executed, understood and implemented.

• Escalate issues and follow them till proper resolution.

• Ensures training record compliance with training matrix and ensures training records are up to date.

• Provide input to relevant SOPs and stand plans/templates with applicable.

• Assist with coordination and implementation of on-boarding of new direct reports ensuring GCT training before study-related activities begins.

• Hold staff accountable for issue escalation to the management team, the sponsor and QA as appropriate and determine regional implications for corrective action plans.

• Hold staff accountable for quality and compliance with project plan and adherence to contract obligations.

• Coach staff to own effective Investigation relations and Investigator oversight when applicable.

• Report status of assigned workload of direct reports and ensure allocation reports are updated.

• Perform weekly review of direct report billable hours and utilizations (in context of project allocation supply and demand); escalate of outliers and assists management team for mitigation.

• Adheres to global tools for monitoring and utilization forecasting.

• Assist with staff recruitment through screening and interviewing.

  • Financial authority in accordance with current signature approval matrix

• Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports.

• Liaise with internal and external customers in relevant process improvement initiatives.

• Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity.

• Support the company/department processes (e.g., Quality Control Visits).

  • Identify, develop, and implement measures to improve the efficiency of the department.

• Responsible for staff time management, PTO and salary reviews.

• Might be requested to work in a client facing environment.

• All other duties as needed or assigned.

YOU NEED TO BRING…

• University/college degree (life sciences preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory).

• 5 years of direct Clinical research experience or combined with other relevant experience (i.e., worked as a Clinical Team Leader/Project Manager at a Pharma or CRO).

• Individual proficiency with managing direct reports or equivalent combination of education and experience to successfully perform the key responsibilities of the job.

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:

• 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.

• Travel Requirements: less than 5% of the time for potential cross-site support needs or external training needs.

Learn more about our EEO & Accommodations request here.