Clinical Operations Manager

Midmark Corporation•Blue Ash, OH

14h

About The Position

JOB SUMMARY: The Clinical Operations Manager is the Clinical Affairs operational lead responsible for organizing, coordinating, and executing clinical activities across Midmark’s healthcare portfolio. Reporting to the VP of Clinical Affairs and Chief Medical Officer, this position ensures the efficient and effective execution of clinical expert engagement and the clinical support for product development and innovation, evidence generation, quality and regulatory initiatives, and other identified business needs. ESSENTIAL/PRIMARY DUTIES: Serve as the operational lead within Clinical Affairs, ensuring that clinical responsibilities, scientific and market insights, and internal and external key opinion leader engagements are executed with high quality and in a timely manner. Manage the recruitment, contracting, internal requests for, and ongoing engagement of Midmark’s network of external clinical experts, either individually or as members of topic-specific Clinical Advisory Panels (CAPs). Responsible for coordination of Midmark internal clinical experts in the Midmark Innovation Process, including the Clinical Solutions Advisor and Clinical Research Manager, to ensure all project attributes requiring internal clinical expertise are duly informed, engaged and completed in a timely manner. Manage the intake, prioritization, planning, and coordination of external clinical expert contributions (CAP) throughout the product lifecycle process and MIP, including requests from Marketing, R&D, Quality and Regulatory (Q&R), Customer Experience, and Commercial teams. Manage and prioritize various requests for Clinical Affairs contributions, outside of known projects or MIP, arising from all other functional areas, including Marketing, Product Development, Q&R, and Customer Experience. Ensure the VP of Clinical Affairs is continuously informed of the status of clinically relevant projects, including timely notification of issues that require executive awareness or intervention. Manage and track progress of clinical initiatives, ensuring deliverables are met on time and within scope. Actively intervene and lead efforts to mitigate delays in deliverables. Ensure, via collaboration with other stakeholders, that the MIP projects are properly budgeted to account for clinical expert contribution costs, V&V cost expectations, and other costs for needed clinical work. Assist functional leads within the MIP process with documentation to support claims and evidence, controlled documents, and regulatory compliance. Execute continuous improvement efforts of clinical operations processes within the Midmark Innovation Process, Clinical Advisory Panels, and other areas of contribution for Clinical Affairs across Midmark. SECONDARY DUTIES: N/A

Requirements

Bachelor’s degree, preferably in healthcare, life sciences, nursing, or related field (advanced degree preferred)
5+ years of experience in clinical operations, healthcare project management, or equivalent industry role (medical device vendor, healthcare institution, or provider group), or equivalent combination of education and experience
Strong organizational and project management skills with proven ability to manage multiple initiatives
Excellent communication and interpersonal skills; ability to coordinate across diverse teams

Nice To Haves

Experience working with clinicians, regulatory/quality teams, and product development organizations preferred

Responsibilities

Serve as the operational lead within Clinical Affairs
Manage the recruitment, contracting, internal requests for, and ongoing engagement of Midmark’s network of external clinical experts
Responsible for coordination of Midmark internal clinical experts in the Midmark Innovation Process
Manage the intake, prioritization, planning, and coordination of external clinical expert contributions (CAP) throughout the product lifecycle process and MIP
Manage and prioritize various requests for Clinical Affairs contributions, outside of known projects or MIP
Ensure the VP of Clinical Affairs is continuously informed of the status of clinically relevant projects
Manage and track progress of clinical initiatives
Actively intervene and lead efforts to mitigate delays in deliverables
Ensure, via collaboration with other stakeholders, that the MIP projects are properly budgeted to account for clinical expert contribution costs, V&V cost expectations, and other costs for needed clinical work
Assist functional leads within the MIP process with documentation to support claims and evidence, controlled documents, and regulatory compliance
Execute continuous improvement efforts of clinical operations processes within the Midmark Innovation Process, Clinical Advisory Panels, and other areas of contribution for Clinical Affairs across Midmark