Clinical Research Manager - CRM

• Provides leadership for the conduct of clinical studies and for the regulatory affairs function as it applies to product approval.
• Studies must be scientifically valid, meet all relevant regulatory requirements and be conducted within ethical guidelines.
• The end result of the clinical studies must be a fair assessment of the safety and efficacy of the tested product (s) and attainment of product approvals in a timely matter.
• Develops and implements regulatory strategies to obtain timely product approvals form worldwide regulatory bodies.
• Ensures regulatory submissions are accurately prepared and comply with regulatory approvals.
• People working within region/country may also have the responsibilities that include:
• Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities.
• Builds and maintains a strong network and close relationship with the various internal and external parties.
• Leads execution for both local and global studies, manages clinical research projects over all of the Medtronic therapies across multiple businesses.

• Accountable for execution for both local and global studies, manages clinical research projects over all of the Medtronic therapies across multiple businesses. Responsible for conducting clinical programs consistent with applicable regulations, guidelines, and policies. Research, prepare, and revise the Investigational Plan (study protocol, Instructions For Use (IFU), report of prior Investigations, bibliography, Case Report Forms (CRFs), etc.) and other appropriate sections in consultation with the cross-functional project team, investigators, data management, and biostatistics.
• Provides management review of relevant clinical documents. Supervise training of investigators, site staff, and Medtronic clinical staff. Supervise site initiation activities.
• Oversee accuracy of clinical studies/projects.
• Develop and manage cost center budget and study budgets.
• Ensures appropriate resources and priorities are maintained for the various projects assigned to their area. Oversees Clinical Research staff with all aspects of their responsibilities. May interface with regulatory agencies, as appropriate.
• Performs personnel related supervisory duties (e.g., performance assessments, development of staff goals and objectives, employee training).
• Collaborate with the Field Clinical Organization to coordinate field staff and clinical site activities with study needs. Provide management level representation during audits.
• Interfaces with representatives from key functional groups (Research & Development, Manufacturing, Sales, Marketing, Regulatory Affairs, and European Clinical Groups) to drive clinical wide or cross-departmental initiatives
• May oversee activities performed by Contract Research Organizations (e.g., CROs, core labs).
• Provide input and support for post-clinical activities and market launch of products. May co-author results of studies for medical literature and/or presentations at scientific meetings.

• Bachelor’s degree required.
• Minimum of 5 years of Clinical Research experience
• Or an advanced degree with 3 years of Clinical Research experience

• Advanced degree (Masters, PhD or MD) preferred. Technical degree defined as engineering, life sciences or related medical/scientific field.
• Leadership skills include strong communication, problem solving, quality focus, business integration acumen, and change management.
• Demonstrated ability to work effectively globally on cross-functional teams.
• Clinical Research experience at Medtronic or within a medical device industry, preferably in cardiovascular area
• Experience managing direct reports and leading clinical teams. Cost-center/budget management experience.
• Experience in medical device clinical product trials and regulations.
• Expertise with Good Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trials
• Experience in clinical trial design, as well as managing clinical trials from start to finish.
• Global clinical trial strategy and execution, and outcomes research study design.
• Product development experience including global clinical strategy development
• Experience in a high-demand and fast-paced environment.

Medtronic