About the Role:Contribute to overall clinical trial strategy and responsible for managing the operational activities to support planning, initiation, conduct and close out phases of clinical studies. Leads and manages the end-to-end operational activities of assigned Clinical Studies (domestic and global studies). Manages studies using multiple Contract Research Organizations (CROs) as well as managing internally run studies. Responsible for integrity of clinical trial data and completeness of Trial Master File (TMF) documentation.
Your Contributions (include, but are not limited to):- Responsible for developing, leading and managing NBI trials on an end-to-end basis and contribute to the overall trial study strategy and planning
- Serves as primary point of contact for clinical operations aspects of assigned clinical studies, may oversee other clinical trials assigned to lower level team members
- Participates, and may lead, in technical and study design discussions and provides expert level counsel and input to clinical trial outlines, protocols, and clinical study reports
- Manages multiple contract research organizations (CROs) and other contract service providers (CSPs) for assigned studies
- Oversees study team meetings and manages study issues. Develops and manages study timelines in accordance with corporate goals. Identifies barriers to enrollment and develops recruitment solutions
- Manages internally run studies (without CROs) including the management of trial monitoring team(s) and develops various study plans, on-site monitoring guidelines, forms, tools and performs onsite monitoring and co-monitoring visits, as necessary
- Works collaboratively with clinical operations department in developing, implementing and enforcing NBI standard processes across all clinical programs
- Manages Trial Master File (TMF) content ensuring all study documents are appropriately filed and inspection ready throughout the conduct of the study as well as at study completion
- Ensures clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies
- Incorporates Risk Based Monitoring with Clinical Quality Assurance counterparts to assure subject safety and data integrity across NBI Development Programs
- May support the recruitment, training, management, and career development of subordinates within the clinical operations group
- Other duties as assigned
Requirements:- BS/BA degree AND 8+ years of clinical trial management experience, including CRO/vendor management (domestic and international), monitoring of budget scope, clinical site monitoring or related experience required. OR
- Master's AND 6+ years of similar experience noted above
- Expert knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive
- Excellent knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out and understands clinical development efforts of trials
- Strong understanding of trial development and extensive trial management protocol and process knowledge across all phases of clinical studies
- In-depth understanding of Clinical Research industry and the relevant environments in which it operates
- Ability to identify and organize clinical resources needed to accomplish major projects, set overall trial(s) objectives and provide clear direction to others; expertise planning activities in advance and taking account of possible changing circumstances; manages time effectively
- Must posses strong presentation and communication skills for internal and external presentations
- Strong computer skills, organizational skills, interpersonal and team participation skills are essential
- Anticipates business and industry issues; recommends relevant process / technical / service improvements
- Demonstrates broad expertise or unique knowledge
- Considered an expert within the company and may have external presence in area of expertise
- Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team
- Ability to work as part of and lead multiple teams
- Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
- Excellent computer skills
- Excellent communications, problem-solving, analytical thinking skills
- Sees broader picture and longer-term impact on division/company.
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
- Excellent project management, strong project leadership skills
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback; experience productively partnering cross functionally and with customers to advance work effectively and efficiently
- Proven ability at analyzing data and information to derive conclusions and drive sound decision making
- Works to improve tools and processes within functional area
#LI-RS1
The annual base salary we reasonably expect to pay is $156,900.00-$214,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
