Job Description:
The Clinical Trial Manager (CTM) position will provide support and/or leadership for one or more global cross-functional clinical studies (includes First-in-Human, proof-of-concept, dose-ranging, special populations Phase II trials). Experience working in a fast-paced, highly dynamic biotech environment is desirable. The CTM is accountable for ensuring clinical trial activities and deliverables within Company and with external vendors are completed on-time and within budget in accordance with the appropriate quality standards including GCP/ICH requirements and applicable international regulations.
Job description and technical requirements:
- Oversee the daily operations of one or more clinical studies including project planning, budget, resource management, and CRO and clinical vendor management.
- Adhere to project timelines and budgets.
- Perform study management activities, including, budget and contract negotiations, study material creation, enrollment tracking/oversight, and report review.
- Develop study related documents and provides guidance for the clinical sites to establish protocol adherence.
- Write routine and ad hoc project updates, as needed, and coordinate project meetings, information, and timelines to assure deadlines are achieved.
- Report study progress/timelines, program updates, achievements, and potential issues/risks to Senior Management.
- Ensure that the conduct of clinical trials is in compliance with ICH, GCP and applicable regulatory requirements and that reported trial data are accurate, complete, and verifiable from source documentation.
- Participate in the assessment and selection of vendors such as CROs, central laboratories, and other specialty service providers, as needed.
- Identification and selection of clinical investigators and study sites.
- Work closely with CRO monitoring team to ensure data entry and site monitoring practices are in line with study requirements.
- Comprehensive understanding of and experience in the drug development process is required including initiation procedures, clinical monitoring functions, drug safety reporting, data flow from external sites to internal processing/review/query resolution, data analysis, and study report generation.
- Represent the company with a high level of integrity and professionalism.
- Adherence to company’s policies and support management decisions and goals in a positive, professional manner.
- Able to recognize need(s), find solutions and take initiative to address in pro-active manner.
- Excellent interpersonal and professional skills are mandatory.
- Strong organizational and time management skills.
- Experience with influencing and negotiating to achieve team delivery; flexible, proactive, and solution-focused.
- Excellent planning and organizational skills.
- High level of initiative and ability to work independently; self-motivated and achievement driven.
- Strong research and analytical skills.
- Able to distill complex information from multiple sources and draw meaningful conclusions and insights.
- Ability to travel domestically and internationally may be required.
- May mentor/supervise junior team members.
- Perform other duties as assigned.
Qualifications and Experience:
- Bachelor’s or equivalent degree in biological science, pharmacy or other health related discipline
- At least five (5) years of Clinical Operations / Clinical Development experience, with 2 years managing clinical trials.
- Phase 1-2 clinical study experience is required, phase 3 experience desired.
- Biotech experience preferred.
- Respiratory and/or infectious disease experience preferred.
- Strong computer skills, including but not limited to the working knowledge of clinical trial management systems (CTMS), electronic document management systems (EDMS), electronic data capture systems (EDC), use of MS-Office products such as PowerPoint, Excel and Word, and experience with Microsoft Project or other timeline software required.
- Highly effective verbal, presentation, and written communication skills; adjusts content and style for audience; effectively delivers key messages; able to manage and communicate with cross-functional teams and stake holders. Fluency in English is required.
- Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
- Thorough knowledge of medical terminology.
- Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
- Able to develop tools and processes that increase the measured efficiencies of the project, and must be able to anticipate obstacles and proactively develop solutions to achieve project goals.