Director of Clinical Operations

JOB DESCRIPTION

Job Title:

Director of Clinical Operations

Department:

Clinical

Reports to:

Executive Vice President, Operations

Classification:

Full Time

Location:

Remote

Travel (%):

25%

Company Summary:

MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.

Please see www.medicept.com for more information.

Position Summary:

The Director of Clinical Operations oversees a global organization of clinical research professionals accountable for the strategic and operational execution of all clinical trials in line with global policies, procedures, and applicable standards of Good Clinical Practice (GCP). This hands-on role will be leading and managing multiple clinical study teams and vendors simultaneously to ensure the studies are completed on time, within budget, and in compliance with SOPs and all applicable regulations.

Essential Duties and Responsibilities:

• Provides expertise, strategic leadership, and direction to Clinical Operations; a global group responsible for planning and implementation of clinical studies.
• Formulate a vision of future state and lead the organization to build tactical plans and teams.
• Anticipates departmental needs, proactively collaborates with other service lines, and influences appropriately to ensure the successful delivery of client work.
• Prepare and maintain current Clinical Operations SOPs.
• Ensure Clinical Operations compliance with company policies and procedures, regulations, guidance, and Good Clinical Practice.
• Develops and implements strategic vendor and partner selection. Is accountable for resolving vendor issues that need to be addressed at the executive level.
• Serve as a mentor for team members, providing guidance on day-to-day clinical operations as needed.
• Grow and develop the Clinical Operations team to enable efficient and high-quality execution of clinical studies.
• Support cross functional and global collaborations as well as commercial input into the development programs.
• Assist clients and collaborators in the implementation of new projects and expanded work scopes
• Proactively anticipates and facilitates future business opportunities with existing and prospective clients
• In conjunction with Sales, develops proposals appropriate to clinical trial work.
• Manages escalation of study related issues and communicates as appropriate.

Skills and Qualifications:

• Bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field
• 10 years of clinical research experience in industry settings, as a director or senior management.
• Knowledge of ICH/GCP, FDA regulations and other health authorities’ regulations, with strong understanding of inspection readiness.
• Global experience in North America and EU is a prerequisite and additional international experience preferred.
• Experience with budget development, negotiation, forecasting, and finance processes.
• Experience implementing large-scale change and process improvements relating to medical operations and/or clinical trials.
• Experience with controlled clinical terminology and clinical trial systems such as TMF/eTMF, CTMS, EDC, IVRS/IWRS, ePRO is highly preferred
• Excellent interpersonal, active listening, and influencing skills
• Strong attention to detail, critical thinking skills to identify and solve problems
• Ability to effectively conduct oral presentations
• Ability to travel as needed

Please note the following:

• Must be legally authorized to work in the U.S.
• Our company participates in E-Verify to confirm the employment eligibility of all new hires in the United States. By applying for a position within our company, you will be required to undergo an employment eligibility verification process through E-Verify as part of our hiring practices.
• MEDIcept does NOT currently sponsor work visas.Relocation is not available for this position as it is a remote role.
• MEDIcept is an Equal Employment Opportunity employer.
• MEDIcept is a drug free workplace.
• MEDIcept adheres to all applicable state guidelines relative to safety precautions.