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Clinical Project Manager

Company: Global Kinetics Corporation
Location: Saint Cloud
Posted on: November 7, 2019

Job Description:

Global Kinetics Corporation, founded in 2007, is a medical device technology business specializing in the precise monitoring, quantification, and reporting of movement patterns of neurological diseases such as Parkinson's disease.
This is a wonderful opportunity to work for a business that has some serious purpose, and people who really care about the work they are doing. Our work environment is fast-paced, with a collaborative family business atmosphere. Small, dynamic and complex and most of all, passionate about delivery innovations that transform the quality of health care and the patient experience. We are looking for like-minded individuals to join our team today!
The position of Clinical Project Manager will be located in our office in Minneapolis and will report to the Director Clinical Research.
Role Responsibilities:
The Clinical Project Manager will provide leadership in the development, coordination and execution of clinical affairs project activities in alignment with business objectives. This position will be responsible for 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 including Sales and Marketing, evaluation of new processes and methods, and achievement of Clinical Affairs departmental corporate goals and objectives on time and on budget. The position may include overview of Clinical personnel.
Primary Responsibilities:
Personnel and Clinical Trial Knowledge Development:

  • Manages and/or mentors other clinical department employees.
  • Enlists support and specifies tasks for various clinical team members to assure meeting study objectives on time.
  • Provides leadership in one or more of the following areas: technical mentoring, supervisory/management, cost center management.
  • Acquires professional, product, market expertise via independent reading, networking, training.
    Management of clinical development plans including design, modification, and evaluation and the implementation of plans for all phases of clinical trials:
  • Provides study management as project leader and/or core team leader of key clinical trial (s) and assures successful conduct of assigned clinical programs consistent with R&D and Marketing plans and applicable regulations/policies. This includes interfacing with representatives from key functional groups including: Clinical Affairs, Quality, Monitoring, Manufacturing, Sales, Marketing, Customer Service, Finance, Regulatory Affairs, R&D, and International/U.S. Clinical Groups.
  • Works with Clinical management to develop department plan, objectives and trial needs assessment
  • Works with Clinical management to determine study objectives, strategy, scope and schedule in order to meet business needs.
  • Reviews and provides input on the investigational protocol in consultation with the cross-functional project team, investigators and the clinical team.
    Management of clinical trial execution activities:
  • Coordinates selection of Principal Investigators and clinical sites.
  • Interfaces with, and ensures training of investigators, site staff and Clinical Affairs staff.
  • Manages the development, review and approval of case report forms (CRFs) for the clinical study.
  • Provides guidance to the Clinical Study Team in development of study materials such as patient brochures, patient recruitment materials, Manual of Operations, study plans (Monitoring, Safety, Data Management, Stats) and Newsletters as required for the study.
  • Interfaces with regulatory agencies as required.
  • Ensures direction to Data Safety Management Board and/or Clinical Events Committees as it relates to project activity, as applicable.
  • Assists in the selection of CRO(s) and vendors.
  • Provides direction and oversees all outside CRO(s) associated with a trial to ensure project deliverables are completed.
  • Adheres to contract, deliverables, data collection/management and other trial associated activities.
  • Develops and manages clinical trial budgets and activation/enrolment forecasts.
  • Provides input and support for post-clinical activities and market launch of products.
  • Works with Clinical Study Team to ensure that all necessary information for post study reports and publications are provided, as applicable.
    Management of key stakeholder and clinical investigator relationships
  • Develops and maintains strong working relationships with steering committee members and key physicians providing input into clinical trial design, execution and publication planning.
  • Develops and maintains strong working relationships with the Clinical Study Team ensuring that the progress and status of the clinical trials is effectively discussed and communicated, and also providing leadership and serving as a role model.
  • Evaluates clinical data/information, convenes and directs investigator conferences to review findings and advise on direction.
    Maintain quality and compliance to all applicable regulatory policies and guidance documents in management of clinical trials
  • Comply with applicable international regulatory laws/standards, including FDA guidance documents, as applicable.
  • Comply with the company's the Code of Conduct, including company-wide and departmental Standard Operating Procedures (SOPs), Department Operating Procedures (DOPs) and work instructions.
    Key Relationships:
    Internal:
  • Clinical department
  • Sales/Marketing/Education & Training
  • R&D
  • Reimbursement
  • Finance
  • OperationsExternal:
    • Clinical study Principal Investigators (PIs) and site staff
    • Physician advisors
    • Contract Research Organizations (CROs)
    • Legal counsel
      --- Skills/Qualifications:
      • Bachelors degree (technical). Technical degree defined as engineering, biological sciences or related medical/scientific field.
      • Master's degree will substitute for 1 year of experience. A PhD or MD will substitute for 2 years of experience.
      • More than seven years of experience directly managing clinical research including pre and post-market trials or similar experience in a medical/scientific area.
      • Knowledge of and proficient skill in using Microsoft Office, specifically, Word, Excel, PowerPoint, Project and Outlook.
      • Ability to lead, work and form strong teams.
      • High attention to detail and accuracy required.
      • Advanced written and oral (including presentation) communications skills.
      • Able to manage multiple tasks efficiently to meet deadlines.
      • Proficient knowledge of medical terminology.
      • Expertise with GCPs and regulatory compliance guidelines for clinical trials.
      • High level critical thinking skills a must - ability to identify problems, identify impact and develop solutions and perform budget analysis and management.
      • Knowledge of clinical and outcomes research study design, methods and statistics.
      • May require up to 30% travel
      • Location: Minneapolis, MN
        Interested? We would love to hear from you!Please send your application and resume to;recruitment
        FLSA Status: Exempt
        Global Kinetics Corporation is an Equal Opportunity Employer (M/F/V/D).

Keywords: Global Kinetics Corporation, Saint Cloud , Clinical Project Manager, Executive , Saint Cloud, Minnesota

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