The Incumbent assists the Vice President of Product Development with the direction, planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. This person will serve as a liaison between the company and contract research organizations, core laboratories, field sites, investigators, study coordinators, physicians and staff members for specific projects or studies, as required by Vice President, Product Development. The Incumbent will assist in preparing regulatory submissions and clinical development strategies for clinical projects, developing protocol(s). The Incumbent will also oversee the development and approval of supporting documents for clinical trial conduct (e.g., informed consent forms, patient instruction guides, case report forms, study manuals) with the objective of ensuring that adequate efficacy and safety information is obtained for all Phase I to IV clinical trials. The Incumbent will also be responsible for the development, editing and maintenance of the Standard Operating Procedures for Clinical Operations.
- Manage and lead all operations related the conduct of clinical trials including:
- Study implementation such as CRO/vendors selection, site selection and qualification, prepare study documents (protocol, CRFs and all study manuals) and coordinate Investigator’s meeting.
- Ensure proper conduct of the study, according to GCP and Leadiant’s, by leading the managing the study operation team.
- Work with QA on preparing and conducting vendor’s and site’s audit
- Responsible for all end of study activities and final study report
- Track enrollment and progress of clinical trials and prepare study newsletters and periodic status reports.
- Manage the review of all site visits reports (including site qualification, site initiation, interim monitoring, and site close-out) and take corrective measures as appropriate.
- Develop and maintain of Standard Operating Procedures within the Product Development Department.
- Develop and support continuation of process improvements and system upgrades.
- Develop and improve business model to meet both regulatory and compliance expectations.
- Manage annual GCP training and other clinical sessions
- Train and supervise study staff on creating and maintaining study files
- Monitor access, compliance, and due diligence activities.
- Coordinate data preparation and presentation to safety review committees and ensure notification of appropriate clinical and regulatory agencies in compliance with the regulations.
- Represent clinical operations for regulatory interactions, investigator and expert advisory board meetings, external professional societies, seminars, and conventions.
- Assistand/or coordinate the preparation of clinical regulatory documents (e.g., IND annual and expedited safety report and NDA/BLA) for filing with the FDA.
- Build and lead a team of clinical operations professionals who embrace the Leadiant values of Rare Dedication, Unwavering Integrity, United in Diversity and Joy in Service.
- Other functions as assigned by the Vice President of Product Development
- Business Continuity:
- Recruitment for open positions; primary point of contact for resume review and interactions with P&C
- Oversee clinical Quality Management System (QMS)
- Train/mentor junior personnel
- 1:1 meetings with direct reports
- Defining and communicating to the team, the study start-up and conduct strategy for the various projects
- Providing written and verbal summaries of budget variances/change in scope for vendors
- Providing monthly financial forecasts for spending to Finance
- Working with key stakeholders to assemble timelines for deliverables across projects
- Working to communicate and ensure postings on ClinicalTrials.gov are maintained and kept accurate
- Annual updates of SOPs
- Providing written updates to Legal/Compliance on auditing activities for presentation to the Leadiant Board of Directors
- Providing written input into protocols, CSRs, SAPs, FDA submission documents
- Oversight of internal clinical audits via the utilization of external auditors
- Initiator of routine revisions and updates of the Clinical Operations internal SOPs
Other functions as assigned by the Vice President of Product Development
- Responsible for meeting timelines and the execution clinical studies insuring that deliverables, milestones, and budget parameters are met.
- Directs investigator performance and adherence to protocol and proactively addresses conduct issues and enrollment problems, as necessary.
- Responsible for supporting contracting efforts with investigational sites, contract research organizations (CROs), clinical laboratories, research consultants and other vendors or external suppliers providing research-related services.
- Assists others in developing/identifying trial goals and develops and distributes project status on process, challenges and opportunities on a regular basis.
- Establishes study milestones and ensures accurate tracking and reporting of study metrics.
- Assists in the review of draft analysis outputs (tables, listings, figures) to be incorporated into the final study reports and regulatory submissions.
- Responsible for the overall direction and, coordination and evaluation of clinical operations staff. Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Provides guidance, mentoring, and support to clinical trial managers, clinical research associates and less experienced clinical operations staff members in all aspects of clinical trial conduct including but not limited to: auditing central files, collecting/tracking and summarizing patient information and occasional monitoring, as required.
- Bachelor’s degree preferably in a scientific field, R.N., B.S.N., or equivalent with a minimum of 5+ years experience in a pharmaceutical, biotechnology or CRO organization. At least 2 years experience leading multiple trials.
- At least four years experience in clinical trials monitoring and clinical trials management, with experience in all phases of the clinical trial life cycle
Licenses & Certifications:
- None required
Specific Job Knowledge, Skill And Ability:
- Knowledge of ICH, GCP, and FDA regulatory requirements.
- Experience in working on an NDA team is plus
- Working knowledge of FDA regulations and ICH good clinical practice guidelines relating to the conduct of clinical studies
- Excellent communication and interpersonal skills
- Excellent listening and collaboration skills
- Ability to challenge and resolve conflict while maintaining clear business focus
- The ability to work across multiple projects/tasks and solve problems in difficult situations.
- Must be able to travel at least 20% of the time.
- Problem Solving – Works well in group problem solving situations.
Leadiant Biosciences, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other legally protected characteristics. The EEO is the Law poster is available here: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to Jobs@leadiant.com and let us know the nature of your request and your contact information.