Clinical Program Manager

Clinical Program Manager will provide global leadership in the development, coordination and execution of clinical affairs activities for an assigned therapeutic area, franchise, or product grouping, providing input to commercial and clinical development strategies in alignment with business objectives.  This position will have responsibility, whether directly or indirectly, for the oversight of Clinical Affairs staff with all aspects of their responsibilities, all project management activities including the successful execution of clinical milestones in compliance with applicable clinical/regulatory standards, facilitation of effective inter-and intra- departmental relationships, evaluation of new processes and methods, and achievement of Clinical Affairs departmental corporate goals and objectives on time and on budget. 

Department Level
    Responsible to provide direction, subject matter expertise, training, and mentoring to support corporate, departmental, and program objectives and ensure the continued development of the team.
    Responsible to develop, create and maintain a highly functional team, complete performance process and promote employee satisfaction and retention within.  
    Responsible to support recruiting efforts, adding input and/or conducting interviews.  
    Perform other clinical duties when requested. 

Program Level (Disease State)
    Responsible for managing the design, development, modification, implementation, and evaluation of all clinical development plans (e.g. budget, timelines, gaps analysis, etc.) for all related clinical projects / trials within assigned Clinical Program which is therapeutic area / disease state focused. 
    Responsible to manage direct / indirect team members on assigned clinical projects to ensure compliance to approved project plans.  
    Responsible to identify and manage risks and business needs. Ensure the development and implementation of leading-edge systems and practices within Clinical Operations and across departments
    Assist in the development of Post Market Clinical Follow-up (PMCF) strategies and post-approval clinical strategies for all assigned program.
    Provide clinical and technical expertise as key stakeholder for applicable cross functional teams.
    Establish / support cross-functional Core Teams to ensure optimal alignment of Clinical, Regulatory, commercial goals, site operations, data monitoring and review, and safety surveillance and reporting expectations.
    Ensure clinical research programs are conducted in accordance with company standard operating procedures (SOPs/DOPs), Good Clinical Practice (GCP), and specific country regulations, as applicable.
    Assist in developing acute and long-term resourcing strategies to support project management, case support, and site management across all projects within assigned program.  
    Responsible to provide management level representation during audits.
    Assist in providing program level update to senior management and prepare periodic reports as required for management review.
 

o    In-depth knowledge of all facets of clinical operations including all applicable US regulations for Medical Devices (e.g. Class III) for pre-clinical and clinical activities, managing CROs, external vendors, and consultants. Working knowledge of OUS regulatory requirement (eg EU, LATAM, AsiaPac).
o    Successfully lead a cross-functional team through the various stages of the clinical product development process (e.g. strategic development, operational execution, and close-out).  
o    Working knowledge of data management (e.g. data review and analysis), and safety surveillance and reporting, and Health Economic and Reimbursement practices.
o    Demonstrated ability to persuasively influence external medical professionals to ensure project deliverables are completed on time and within budget.
o    Strong command of GCP/ ICH guidelines. 
o    Effective analytical and problem-solving skills.  
o    Track record of successful management experience. Experience with management of internal and external resources within a on-site and remote environment.  
o    Demonstrated leadership to develop, motivate and guide subordinates to meet objectives 
o    Excellent interpersonal and effective verbal and written communication skills and be able to effectively work across departments with diverse needs.
o    Excellent organizational and time management skills.
o    Ability to work in a highly matrixed team environment.
o    Ability to adapt to changing priorities.
o    Experience with or desire to use experience to create innovative infrastructure and "best practices" in concordance with core purpose is highly desirable.
o    Knowledge of and skill in using Microsoft Office suite (eg Visio, PowerPoint, Word, Excel,, and Outlook).

o    Bachelors degree in Biology, Chemistry, Sports Medicine, Nursing, Engineering, or Health Sciences field required or Advanced degree strongly preferred; or equivalent combination of education, training and experience.  
o    Minimum 15 years medical device Clinical Research experiences and developing clinical strategies to support base business requirements required. 
o    Minimum 10 years direct experience managing clinical research studies, financial modeling, monitoring and compliance, and/or vendors associated with CRO, Stats, Data Management, Safety Surveillance, Market Access, and Medical Writing initiatives required.
o    Minimum 3 years Indirect / direct management of employees strongly preferred.
o    Must have experience with site and sponsor level FDA BIMO investigation(s).
o    Experience supporting multiple clinical projects and/or Global Clinical trials (e.g., Europe, Japan, Canada, China, etc.) and general knowledge of the regulatory and clinical requirements for each region preferred. 
o    Strong understanding of the clinical trial process and associated ICH, GCP, FDA and EU regulatory pathway and requirements; required.
o    Experience supporting / managing site and sponsor level FDA BIMO investigation(s) strongly preferred.
o    Experience collaborating with Marketing, Sales, Professional and Clinical Education (PACE), Medical Affairs and Field Clinical to generate clinical evidence to support current and long-term claims matrix preferred. 
o    Experience supporting New Product Development initiatives and post market clinical strategies; strongly preferred.
o    Peripheral and/or Cardiovascular clinical trials strongly preferred. 
o    Demonstrated strong track record of leadership, collaboration and people development.