Clinical Trials Lead
The Clinical Trials Lead (CTL) will generate quality data to support regulatory filings for Synergy drugs by planning and executing clinical trials on time and within budget. The CTL will provide guidance and clinical trial management expertise through regular status updates regarding timelines, budgets, quality, etc., as well as the identification and timely resolution of critical issues requiring intervention (e.g., safety issues, issues requiring protocol amendments, issues affecting adherence to study, timelines, budget, and quality).
Study Documents: The CTL is accountable for all study documents for assigned studies. Select documents will be approved by the CMO.
- Prepare Protocol and ICF and may assist with preparing key documents such as, Investigator Brochure, FDA Briefing Documents, internal/external presentations, etc.
- Develop and approve assigned study budget(s)
- Prepare Protocol amendments
Study Start up and Oversight:
- Accountable for the identification, bid process, and final selection of vendor(s)
- Oversee vendor identification and activities. Resolve issues timely.
- Finalize Study Specific Oversight Plan with CMO
- Establish strategies for the collection of data, selection of sites, issue identification, monitoring and investigator communications
- Work with the CMO to complete Site Selection, Monitoring, Safety, Data Management, Project Management, and Site Close Out plans
- Prepare protocol training slides for use at site initiations and investigator meetings
- Successfully execute Investigator Meetings or site initiations
- Review and approve vendor user requirement specifications for systems, devices and diaries utilized in assigned study(ies)
- Accountable for the successful execution, enrollment and quality of the assigned clinical study(ies) within project timelines
- Develop operational strategies and quality plans for the conduct of assigned study(ies)
- Manage and approve study budget(s)
- Contribute to the development and management of study specific portals, metrics and status reports
- Monitor the quality data, site performance, and managing investigator relationships
- Ensure timelines and key milestones are met
- Review and evaluate criteria for blinded listings, tables and figures
- Develop and Manage the Data Management Plan for assigned study(ies)
- Establish contingency plans for recruitment
- Monitor portals and set up system to monitor, identify and resolve issues
- Contribute to study newsletters and investigator communications in collaboration with the CMO
Risks and Issues:
- Responsible for the management, tracking, and trouble shooting of a study or series of studies
- Identify site and study level issues and work to resolve and mitigate
- Communicate and escalate issues as appropriate to CMO
- Line manages junior staff as assigned and provides mentoring and coaching
- Sets goals and objectives for direct reports and conducts mid and year-end performance appraisals
- Oversee the management of clinical supplies with Drug Supply manager and appropriate use of IWRS
- Management of study specific documentation in the electronically secured shared drive
- Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites and vendors
- With the CMO, maintain consistency and standards (for both process and project) across study or studies for all investigational sites
- Complete the training of internal staff for the specific protocol(s) and obtain documentation of training
- Establish project specific procedures and disseminate study information to the appropriate parties
- Issue status summaries and escalate issues to senior management as required
- Assist Clinical Research Physician or CMO to make recommendations, act, and provide options for issue resolution related to study
- Arrange for study coverage when out of office
- Approximately 20% travel required
- Excellent interpersonal, influencing and communications skills
- Strong leadership, relationship management, and negotiation skills
- Detail-oriented and well-organized
- Ability to organize, provide direction and motivate teams
- Ability to prioritize and manage multiple tasks efficiently
- Encourage mutual respect and accountability at all levels
- Minimum 10 years' experience in clinical development, which includes the development and management of timelines, study budgets, resource allocation and management, clinical trial monitoring, issues identification and resolution for Phase 2-3 Clinical Research Studies
- Demonstrated success in planning, executing and delivering quality studies on time and within budget
- Five years of management experience
- Proven management skill including providing guidance, clinical trial management and direction to Clinical Research Assistants/Monitors and vendors
- Prior experience managing clinical studies utilizing diaries or other patient reported outcomes-preferred
- History of collaborative relationships with Principal Investigators and Development Partners
- Ability to work across several therapeutic areas. GI Research experience preferred
- Extensive medical/scientific and clinical research knowledge
- Experience in protocol development, implementation, and study report preparation.
- Proficient at data interpretation, developing study related documents and contributing to IND safety updates
- Experience in all aspects of the clinical development process
- Knowledge of GCP and ICH Guidelines essential
- New York, NY
NOTE: This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.
- NO PHONE CALLS PLEASE AND NO AGENCIES OR RECRUITERS.
Please fill out the form below to submit your application.