TEMPLATE - Executive Director, Clinical Operations (Clinical)

  • 800 Hillgrove Ave, Western Springs, IL 60558, USA
  • Employees can work remotely
  • Full-time

Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Job Description

The Senior / Executive Director of Clinical Operations has the responsibility of the oversight, planning, initiation and execution of Clinical Operations programs as directed by the Vice President, Clinical Operations.

Essential Functions Include:

  • Work with the Business Development Department on identifying new or expanding opportunities.
  •  Lead Clinical aspects of RFI and RFP preparation.
  • Assist in the preparation of internal start up meetings for new projects.
  • Coordinate, attend, and lead client visits and teleconferences as indicated.
  • Oversee or participate in clinical tasks as needed.
  • Manage and allocate internal and external resources across Clinical Operations projects based on experience and training. Recognize potential gaps and proactively plan.
  • Supervise overall study management by monitoring deliverables, schedules, timelines and external team resources.
  • Strategically identify possible improvements to current processes, determine new processes that are needed and initiate and implement new processes.
  • May be used as a clinical resource for a project or to reach a milestone.
  •  Train, mentor and supervise Clinical Operations personnel.
  • In conjunction with the VP, Clinical Operations leads Clinical Operations quality or process initiatives.
  • Lead Clinical Operations metrics preparation and correct allocation of staff.
  • Lead author training programs for clinical operations personnel on new processes.
  • Acts independently, has fully developed communication and vendor management skills and takes initiative and action based upon strategic guidance from VP, Clinical Operations.
  • Advises VP Clinical Operations of study specific issues, priorities, and problems. 
  • Proposes proactive, innovative ideas to help resolve challenges faced by the clinical team and the cross functional development team(s).
  • Serves as a primary or secondary study team contact to manage the Clinical Operations of the trials and communicating team objectives to ensure quality and success.
  • Leads the development of the investigator budget. Ensures effectiveness of site budget/contract process.
  • Directs the development of study related documents such as monitoring guidelines, monitoring plan, source document templates, monitoring visit report templates, site tools and worksheets.
  • Oversees and contributes to the design and development of case report forms (CRFs), CRF guidelines/instructions, and Data Management Plan.
  • Assures clinical trials are in compliance with good clinical practices (GCPs) and in accordance with the FDA and/or EMEA regulations and ICH guidelines.
  • Assumes a leadership role to ensure the Clinical Operation milestones and timelines are achieved.
  • Travel may be required.

Qualifications

Qualified candidates must have:

  • Bachelor’s degree required, preferably in a scientific or healthcare discipline.
  • Senior Director: At least 12 years of experience working in clinical research (preferably in a CRO and sponsor company).
  • Executive Director: At least 15 years of experience working in clinical research (preferably in a CRO and sponsor company).
  •  At least two years of experience working as a Clinical Research Associate (CRA/monitor).
  • Greater than 5 years of experience in a leadership capacity including managing direct reports.
  • Excellent verbal, written communication skills and interpersonal and presentation skills are required. 
  • Working knowledge and experience with Microsoft Office including Outlook, Word, PowerPoint and Excel.
  • Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials. 
  • Must be able to prioritize multiple tasks, plan proactively, and set and accomplish goals using well-defined instructions and procedures. 
  • Ability to develop tools and processes that increase measured efficiencies of the project.
  • Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.

Additional Information

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***