Senior Clinical Trial Manager

Company: PharmaOut
Location: Dayton
Posted on: January 15, 2022

Job Description:

Our client is looking for a Senior Clinical Trials Manager to join their growing team.
The Senior/ Clinical Trials Manager will assist in the planning and conduct of clinical studies He/she will manage operational and logistical tasks of clinical operations to ensure efficient execution of clinical trials from start-up through to database lock and closeout activities within established budgets and timelines, ensuring all activities occur with high quality and in compliance with the appropriate FDA regulations and quality standards including GCP/ICH, NDA, 505(b)(1), 505(b)(2), regulatory pathways and all SOPs. The Sr/CTM will assist with the preparation of study related documents, plans and materials, identification of study risks and contingency plans, appropriate escalation of issues and oversight of CROs and vendors. Essential Functions:

• Lead project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including, but not limited to: development of trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• Develop, contribute to, and review core study documents including protocol, ICF, and study plans.
• Perform oversight of clinical study CROs and vendors.
• Assist in negotiation of trial site contracts and budgets.
• Assist in submission to IRBs/ECs
• Provide support for regulatory submissions for the program, including tracking and collecting key deliverables.
• Forecast and manage trial budget to ensure accurate finance reporting and trial delivered within budget.
• Review and approve Monitoring Visit Reports and identify issues and/or trends across a trial project and escalates deviation issues.
• Relationship building with KOLs, sites and patient advisory groups.
• Liaise with cross functional team including regulatory, quality, finance, and clinical study supplies and be able to understand interdependencies to ensure seamless trial execution.
• Participate in design, develop, and testing (UAT) of study databases.
• Partner with Drug Supply Management on the forecasting, planning and delivery of study product globally.
• Participate in site and vendor audit preparation
• Review and track KPIs and to ensure delivery of clinical aspects for all studies, including metrics related to study startup timelines, data entry timeliness, and data quality.
• Perform project management, including risk assessment and contingency planning.
• Maintain communication (email, verbal, meetings, etc) with stakeholders (including vendors) as well as external corporate partners (as applicable) to ensure clear and consistent messaging.
• Comply with relevant training requirements.
  Skills
  • Deep understanding of clinical trial operations and management of clinical trials at investigator sites as well as of site-level quality and GCP, including best practices for drug management, regulatory, source data, clinical supplies, and all study related activities.
  • Multitasking ability to oversee a large number of tasks and reach milestones on time
  • Strong written and oral communication skills with incredible attention to detail
  • Willingness to roll up your sleeves and get in the weeds of projects as a jack of all trades
  • Ability to think outside of the box and challenge the status quo
  • Natural entrepreneurial spirit with unrelenting dedication to delivering results
  • Desire to work in a fast-paced, innovative environment
  • Experience with various computer systems/database; a willingness to learn new systems/databases, including but not limited to: eCRF, ePRO and IRT.
  • Comfortable reviewing clinical study data and interpreting findings.
  • Excellent ability to prioritize activities.
  • Results-driven in terms of timelines and quality.
  • Comfortable operating in a fast-paced environment with a high degree of ambiguity.
  • Must be analytical, detail oriented, hardworking, organized, and willing to wear multiple hats in a startup environment.
  • Ability to thrive and be highly effective in a small office work environment.
  • Ability to communicate effectively in presentations
  • Conscientious about timeliness of assignments and quality of work product
  • Able to handle multiple tasks and maintain control and order over same
  • Exceptional work ethic
  • Excellent interpersonal and communication skills (verbal and written).
  • Self-motivation, flexibility, attention to detail and organizational skills.
  • Excellent ability to work in a team environment and equally comfortable working independently on assigned tasks.
  • Solid project management skills. Education:
    • BA/BS in science field, advanced degree (MS, PharmD, MPH, PhD) strongly preferredExperience:
      • 5-7 years' experience in clinical operations at a Biotech, pharma or CRO; 3-5 of those years with direct trial management (study start-up through close-out)
      • Experience working in rare disease, pediatric or dermatology indications is preferred, however no specific therapeutic experience is required

Keywords: PharmaOut, Trenton , Senior Clinical Trial Manager, Executive , Dayton, New Jersey