Director, Clinical Operations / Madison, WI (ONSITE)

Fortrea•Madison, WI

1d•Onsite

About The Position

Director, Clinical Operations 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 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: 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.

Requirements

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.
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.

Responsibilities

Has a deep understanding of the industry, market and our clients and is able to present Fortrea’s 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 Fortrea’s capability, visibility and position through publications and presentations at conferences, meetings, webinars etc.
Provide costing direction to commercial team for associated services.
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.
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.