Clinical Research Manager – CRM

Clinical Research Manager – CRM

Requirements

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

Responsibilities

• 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 from worldwide regulatory bodies.
• Ensures regulatory submissions are accurately prepared and comply with regulatory approvals.
• Represents Medtronic from a clinical research perspective 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.

Preferred Qualifications

• 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.