Director of Clinical Trials from Joulé

Title: Director, Clinical Trials
Location: Hybrid,  Onsite, Oakland, PA : 3 days a week onsite and 2 days remote
Schedule: M-F 8 am-5 pm
Type: Direct-Hire/Permanent 
Salary: 6-figures !
Start: January 2025

Overview:
A top-ranked research university is currently searching for a DIRECTOR, OFFICE OF CLINICAL TRIALS. The director will work with the Clinical Research Leaders to oversee the clinical research mission's growth, management, oversight, and overall quality. This position ensures the success of its goals, maintains high-quality clinical research, and ensures effective management and resources of all activities, processes, and overall performance.

Responsibilities

• Leads the development of strategic goals for the growth and development of the clinical research program in support of the overall vision and mission of our client.
• Oversees the implementation of these goals and actively monitors progress toward goals.
• Demonstrates expertise in Clinical Trials Management Systems (CTMS).
• Work collaboratively with peers in the development of the budget for the office and oversees the allocation of discretionary resources.
• Provides leadership or nominates and oversees the leadership of other clinical research related committees
• Promotes close interactions between clinical scientists in collaboration with Program Leaders, and administrative leadership.
• Effective at managing the Standard Operating Procedures/Standard Work Procedures for the office and research community.
• Help to establish metrics to ensure high quality work product and identifying opportunities for procedural improvement.
• Help to define policies, procedures, and training and documentation requirements to support effective, well communicated and timely process and policy changes.

• Bachelor’s degree in addition to a minimum of 10+ years of clinical research and/or related experience. At least 5 years in a leadership or supervisory role.
• Process improvement experience.
• Excellent written and verbal communication skills are essential.
• Working knowledge of the Common Rule (45 CFR 46), the Privacy Rule (45 CFR 160, 164) and the regulations that govern human subjects research issued by the Food and Drug Administration (21 CFR 50, 56), and others as needed.
• Strong understanding of current standards for Good Clinical Practice (GCP) guidelines defined by the International Committee on Harmonization, FDA, NCI/NIH, OHRP, and the Office of Civil Rights, and according to state and institutional regulations.
• Able to apply broad technical, clinical/professional knowledge and significant job-related experience.
• Excellent writing capabilities, including the ability to write reports and business correspondence.
• Experience of legal language (contracts, confidentiality agreements, etc.).
• Expertise in financial (budgetary) source costing (NIH, Pharma, Foundation).
• The ability to analyze and prepare clinical study costing tools.
• Working knowledge of all types of clinical trial sponsors: federal grants and subawards, foundations, investigator initiated trials and industry funded.
• Preferred Qualifications:
• Master’s degree in business and healthcare administration or other related field
• Prior experience with design, roll out and implementation Clinical trial management systems
• Prior experience leading a team through period of reorganization or dramatic change.