We are seeking an experienced Manager, Clinical Operations Consultant with the potential to transition to full-time employment to support activities for RegDev, Inc’s clinical operations team by supporting clinical related inspection readiness and clinical operations activities for RegDev clients.

Essential Duties and Responsibilities

Clinical Operations and Clinical Study Project Management

• May include preparation and coordination activities of clinical trial set-up, maintenance and closure in accordance with GCP and current SOPs.
• May include providing study management and/or vendor management activities for RegDev clients.
• Actively support other functional groups with clinical trial set-up, maintenance and closure (e.g. data management, statistics, medical writing, clinical trial material vendors, etc.)
• Provide expertise and direction in the activities involved with planning, conducting and reporting of clinical data.
• May include trial initiation activities including protocol development or support, activities for investigator site selection and regulatory preparedness, investigator budget and contract negotiation, and clinical vendor procurement activities.
• Support overall study progress including development and maintenance of timelines, risk mitigation and contingency plans for all aspects of trial conduct, and management of study scope and change control.
• Support study oversight to monitor adherence to GCP with timely and appropriate escalation of issues as necessary.
• Conduct eTMF QC for RegDev clients.
• Support Mock and actual regulatory inspections for RegDev clients.
• Participate in the development and review of regulatory documents as appropriate.

Vendor Management

• Meet with and gather information on new vendors to build a knowledge base and maintain understanding of available services.
• Complete or support vendor proposal requests as required and actively participating in the review and selection process of clinical vendors.
• Ensure adherence to business processes with respect to vendor contracts and invoicing procedures.
• Serve as liaison with project and site management clinical research organizations (CROs) and monitor adherence to contracts and budgets.
• Participate in quarterly trial budget reviews and invoice reconciliation.

Quality and Process Improvement

• Participate in development and review of clinical SOPs.
• Maintain 100% compliance with SOP training.
• Conduct and/or support audits and inspection readiness visits to investigator sites and vendors.
• Promote and/or support process improvement initiatives consistent with GCP operations and project management tools and concepts.
• Manage and support Clinical Operations Inspection Readiness related activities.

Job Requirements and Education

Education

• Bachelor’s degree in life science field, master’s degree preferred.

Experience:

• Minimum of 8-10 years’ experience in the pharmaceutical industry.
• Practical experience in initiating, maintaining and terminating clinical trials.
• Experience with management of CROs or other vendor relationships.

Other Skills and Abilities:

• Excellent oral and written communication skills.
• Excellent self-management and organizational skills with the ability to independently manage multiple projects and adjust workload as necessary.
• Appropriately escalate issues when necessary, bringing a full account of issues to the table with suggested resolutions and recommendations.
• Thorough understanding of project management tools and processes (e.g. management of integration, scope, timeline, cost, quality, resources, communications, risks and procurement).
• Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
• Proficiency with MS Office applications including Excel, Word, and PowerPoint.  Proficiency with MS Project preferred.

ADA Notations

• Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
• Regular communication (hearing/speaking).
• Approximately 10% travel is required, overnight travel required as needed.
• Routine home and onsite office duties including computer keyboard use.
• Vision requirements include close vision and ability to focus.
• Noise conditions range from quiet to moderate – home office conditions variable.

EQUAL OPPORTUNITY EMPLOYER