Director, Clinical Operations Madison, WI (ONSITE)

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 Director 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:

Senior and experienced leader expected to leverage that experience to aid a team to grow an innovative and profitable business oversee the design of effective and differentiated strategies for operational delivery with clients and oversee the portfolio of studies being conducted in Clinical Pharmacology Services. Expected to establish and grow client relationships be seen as an industry leader be an effective line manager and engage as a leader and subject matter expert in relevant process improvement and change management activities.

Other key responsibilities:

• Has a deep understanding of the industry market and our clients and is able to present Fortreas Clinical Monitoring capabilities. Leads growth within the business develops and designs innovative winning trial solutions that result in profitable portfolio growth.

• Owns client expectations and satisfaction identifies develops and fosters new and existing strategic relationships at senior operational levels with clients vendor partners etc. and guides teams in building long term client relationships.

• Markets and supports Fortreas capability visibility and position through publications and presentations at conferences meetings webinars etc.

• Provide costing direction to commercial team for associated services.

• Leadership:

• Engages with Fortrea leadership to help define drive and implement innovative strategic initiatives.

• With the PIMS leadership team define develop and implement the CPS vision and strategy translating into initiatives and operational plans.

• Partners with peers ensuring consistency (quality standards policies processes and practices) across the business.

• Attracts develops and retains high performing talent; strengthens and deepens talent bench and succession.

• Governance committee member or chair for at least one strategic client.

• Responsible for ensuring effective training utilization development and performance of all staff.

• Subject Matter Expertise:

• Responsible for appropriate management and resolution of performance issues.

• Prioritize and coordinate appropriate training initiatives to ensure compliance with policies and procedures globally.

• Oversight of Contract CRA and Vendor Management.

• Ensures effective resolution of escalated ICH/GCP issues identified through regular interactions with direct reports and conduct of Clinical Quality Control (CQC) Visits.

• Contribute towards global coordination of approvals for relevant SOPs and standard plans/templates for use by Clinical Operations staff.

• Hold Clinical Operations staff accountable for ICH/GCP issue escalation to the management team the sponsor and QA as appropriate.

• Hold Clinical Operations staff accountable for quality and compliance with project plan and adherence to contract obligations in Source Data Verification Monitoring Visit cycles Trip Report quality and on time deliverables.

• Coordinate corrective action plans for utilization outliers per the quarterly and annual budget plan.

• Assist in the coordination of global tools for monitoring and utilization forecasting.

• Supports global resource management activities.

• Coordinates improvements to standardized processes and tools in alignment with associated policies to ensure efficiency and productivity.

• Develops strategies to control and improve financial margin and minimize write offs across programs or projects.

• Effectively and proactively resolves conflicts as needed.

• Responsible for the review and assessment of ongoing program profitability.

• Implement and monitor progress against project and program plans and empower teams to revise as necessary.

• Lead departmental project metrics demand high performance on realization of initiatives.

• Monitor team performance and facilitate adjustments when necessary to ensure goal attainment.

• Lead project program and department resource needs and contribute to contingency planning for key resources.

• CAPA council leadership role for CPS Clinical Monitoring.

• Develop strategic client metrics and track project metrics across program as needed. Monitor and report KPI for strategic relationships actively managing to ensure they are within the scope of the contract and initiate process improvements to address variance.

• All other duties as needed or assigned.

Education / Experience:

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

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

YOU NEED TO BRING

• Minimum of 7 years as a Line Manager or Project Manager required.

• Minimum of nine (9) years relevant clinical research experience in a pharmaceutical company/CRO.

• Detailed knowledge of financial control procedures (e.g. costing systems time reporting).

• Detailed knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.

• Broad knowledge of drug development process and client needs.

• Additional experience may be substituted for education requirements

• Individual is proficient with onsite monitoring activities (including pre-study initiation routine monitoring and closeout visits).

• Thorough knowledge of drug development process.

• Thorough knowledge of relevant SOPs ICH and GCP/GMP guidelines.

• Demonstrated ability to lead by example and to encourage team members to seek solutions.

• Proven interpersonal skills.

• Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.

• Demonstrated ability to lead by example and to encourage team members to seek solutions.

• Excellent communication planning and organizational skills.

• Ability to negotiate and liaise with clients in a professional manner

• Ability to present to staff at all levels.

• Excellent planning and organizational skills.

• Excellent oral written and presentation skills.

• Experience in leading projects and project teams in a virtual environment.

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:

• General Office Environment or Home-Based.

• Must be able to sit at a computer for long periods of time.

• Must be able to use hands to finger handle or touch objects tools or controls including a computer keyboard for up to 8 hours per day.

• Will involve out of normal office hours as required by the role.

• Travel is primarily to USA/UK/EUROPE up to 10% of the time with up to 80% of that time requiring an overnight stay.

• Ability to drive and have a valid drivers license as appropriate per country travel norms.

Learn more about our EEO & Accommodations request here.