Senior Manager, Clinical Strategy & Operations

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This position is responsible for leading clinical operations globally and supporting clinical strategy development for the Clinical Science & Office of Medical Affairs department in Interventional Urology. The role is responsible for driving and managing operations to support the priorities of the Interventional Urology business, as well as to contribute to the development of clinical strategy as required. This position will lead the clinical operations team and ensure compliance of regulations and ensure clinical activities comply with organizational SOPs and global regulatory requirements in all relevant geographies.

 

Major Areas of Accountability

• Develop and implement strategy for globally aligned clinical operations, including aligned processes, procedures and execution
• Lead the clinical operations team, including employee development and engagement
• Plan clinical studies and oversee management of clinical studies, including development of clinical investigation plans for regulatory and marketing purposes
• Drive procedure process development and improvement, including management of the development process for critical study documents (e.g., protocol, amendments, IB, ICF, and CRFs)
• Identify and implement appropriate clinical trial tools and management system(s)
• Ensures training to support clinical trial activities is developed, implemented, and maintained
• Develop and maintain oversight of assigned study budgets and forecasts
• Identifies and escalates study risks in a timely manner to appropriate stakeholders, providing a mitigation plan where applicable
• Effectively captures and communicates feedback and data with the Product team to continuously improve user experience
• Creates clinical trial updates/reports and communicate with cross-functional stakeholders
• Provide clinical operations input in the identification, evaluation, and selection of CROs and vendors (e.g., central IRB, central labs)
• Manage relationships with applicable CROs and other external vendors
• Responsible for the quality of all study-related documentation (e.g., Trial Master File, site qualification and initiation visits reports, interim monitoring visit reports, clinical monitoring plan, informed consents, CRF completion guidelines, etc) during the study start-up and throughout the life of the project to ensure that procedures are followed in an appropriate and consistent manner
• Manage and oversee team activities including appropriate resourcing of staff, quality control, and successful project delivery
• Manage and develop staff to ensure their performance meets/exceeds both business and their own personal goals/objectives through training, mentoring, and allocating staff according to their ability
• Identify and implement tools to improve clinical study efficiency
• Attend professional conferences
• Support Investigator Initiated Study Program (IISP) as assigned
• Support the development of clinical strategy for new and existing products
• Process and review clinical study data using Good Clinical Practices (GCP) data-handling procedures and guidelines.
• Conform with Coloplast Code of Conduct and all local Compliance Standards
• Conform with Coloplast Q/EHS Policy
• Other duties as assigned

 

Basic Qualifications

• 7+ years of relevant project management experience
• 7+ years’ experience within clinical research, preferably with medical devices
• 5+ years’ experience people management, global management preferred
• Demonstrated ability to manage and motivate direct reports
• Masters or Doctorate degree (preferably in health science or biot