Associate Director/Director - Clinical Oversight, Training and Standards
The Job Details are as follows:
Direct all Clinical Oversight activities across CTMS, Oversight, and Training and Standards groups to ensure the delivery of high quality, compliant clinical trials; ensuring inspection readiness at all times. Provide vision, leadership, mentoring and coaching to Clinical Oversight staff and direction to the organization to ensure continuous improvement in quality and adherence to standards and regulations.
Key Accountabilities / Responsibilities
- Develop, maintain, and enforce Clinical Operations Quality Management Plans to ensure appropriate UT/vendor oversight and prevent quality issues during the conduct of clinical trials. Interact with strategic partners to provide oversight to outsourced clinical activities.
- Direct staff to ensure proper set-up and oversight of clinical vendors and CROs
- Continuously assess and ensure clinical study metrics are relevant and provided to upper management routinely.
- Collaborate with Clinical Operations staff and GCP Compliance to provide expeditious resolution to quality issues; identify trends from site audits and make recommendations to Clinical Operations management to respond to and improve overall findings and reduce future findings. Ensure clinical trials are being conducted in accordance with current ICH/GCP, FDA, EMA and global regulations.
- Develop and implement corrective actions/preventative actions (CAPA) when necessary.
- Develop and implement department Inspection Readiness plan in collaboration with clinical operations staff.
- Direct the process of development and maintenance of policies, SOPs, work practices and forms within Clinical Operations; leading and defining operating principals and collaborating with international counterparts to ensure global consistency and appropriateness.
- Interact with strategic partners to develop and document an appropriate SOP matrix; conducting a SOP gap analysis if needed and leading continuous improvement initiatives to increase quality.
- Collaborate with senior management to identify and provide training needs; oversee design, delivery, and facilitation of high quality training to current and new-hire Clinical Operations staff to improve individual and team performance.
Perform other duties as assigned
- BA/BS degree in a scientific field
- 15 years in biopharmaceutical research & development or CRO, with 8 years as a CRA and/or Clinical Manager in the biopharmaceutical industry and 5 years’ experience with staff leadership in a supervisory role
- Experience developing SOPs and department processes
- Strong knowledge of US FDA, EU and GCP and local regulations
- Experience assessing deviations and determining appropriate corrective and preventative actions (CAPA); experience with CAPA Management systems (such as Trackwise)
- Experience training and mentoring clinical research staff
- Strong CTMS and LMS experience
- Proficiency with Microsoft Word, Excel, and PowerPoint, and web conferencing systems
- Strong time management, prioritization, and organizational skills; ability to multitask and prioritize in a fast-paced environment
- Excellent internal and external customer service with strong communication and interpersonal skills
- Attention to detail and accuracy in work.
- Ability to travel as needed up to 30%
Preferred Knowledge, Skills, and Abilities
- Advanced degree (MS, MPH, PharmD, PhD)
- Experience with all phases of clinical research
- Prior experience and knowledge in pulmonary therapeutic area
- ACRP or other GCP-related certifications a plus
- Experience with regulatory authorities and/or quality assurance audits
- Experience with eTMF, OneDrive, and SharePoint
- Ability to work independently and as part of a multi-functional team
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities