Clinical Operations Manager is responsible for the execution of Cerapedics pre- and post-market clinical trials including study set-up and execution, vendor management and sponsor oversight activities.
Specific Functions and Responsibilities:
- Leads the execution of Cerapedics clinical studies - s/he is a hands-on leader. (e.g. site qualification & initiation, contract negotiations, budgeting, working with the sites and CRO’s deliver on commitments).
- Develops and manages the overall project & development plan for our clinical programs, instilling accountability, enthusiasm and commitment across all internal team members and the external partner organizations (CRO’s, contractors, suppliers, etc.).
- Site selection and feasibility assessments, initiation; in collaboration with CRO’s.
- Accountable for creating and meeting critical timelines, budgets, and objectives, proactively identifying project risks and mitigation strategies.
- Runs key cross-functional meetings, consolidates functional inputs to develop an integrated project schedule, resource plan, and budget.
- Drives and manages the analytics & reporting for key work streams, including weekly cross-functional team meetings (status reports, minutes).
- Monitors critical timelines and goals, proactively managing to potential hurdles, assuring that functions stay on track and budget; develops dashboards, meeting minutes that effectively communicate the status of the program and associated risks. (e.g. drug supply, ancillary supportive clinical studies, regulatory milestones).
- Prepares and, in collaboration with senior leaders, enables milestone review meetings, generating relevant scenarios, strategies, recommendations, etc.
- Efficiently plans and implements key meetings including Investigator meetings, DSMB meetings, and supports team members in implementing select activities.
The above description outlines the most common job duties; however, it does not exclude other potential work assignments.
Education or Formal Training Required:
- BS/BA with preferred 10 plus years of experience OR MA/MS/MBA with preferred 8 plus years of experience OR PhD with preferred 5 plus years of experience.
- Experience with orthopedic clinical studies a plus.
Qualifications Required: (knowledge, skills, abilities, initiative, judgment, etc.)
- Experience in managing clinical studies in all phases.
- Experience with total product lifecycle from IDE to PMA or equivalent.
- Thorough understanding of FDA, EMEA, and ROW ICH and GCP guidelines, as well as thorough understanding of cross-functional clinical processes including and not limited to data management, biostatistics, medical monitoring, drug safety, and regulatory affairs.
- Experience with regulatory compliance audits and inspections.
Work Conditions / Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully preform the essential functions of the job. Reasonable accommodations may be made when requested by the employee to enable individuals with disabilities to perform the essential functions.
- This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely.
- This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs.
- This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination.
- Minimal supervision. A wide degree of latitude is expected. Relies on experience and judgment to plan and accomplish goals.
- This is a field-based position. Candidates located in Canada, Pacific Northwest, Upper Midwest, or Northeast preferred.
Travel Requirement: Up to 80%
Benefits/Compensation (including but not limited to)
Medical and dental insurance, group life insurance, 401k matching, long term disability, potential target bonus, paid time off.
Salary Range: Dependent on country of residence. This position is not possible to do from Colorado.