Clinical Project Manager
Company: Global Kinetics Corporation
Location: Saint Cloud
Posted on: November 7, 2019
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
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 and Clinical Trial Knowledge Development:
- Manages and/or mentors other clinical department
- 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
- 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
- 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
- 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
- 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
- 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,
Management of key stakeholder and clinical investigator
- 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
Maintain quality and compliance to all applicable regulatory
policies and guidance documents in management of clinical
- 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.
- Clinical department
- Sales/Marketing/Education & Training
- Clinical study Principal Investigators (PIs) and site
- Physician advisors
- Contract Research Organizations (CROs)
- Legal counsel
- Bachelors degree (technical). Technical degree defined as
engineering, biological sciences or related medical/scientific
- 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)
- Able to manage multiple tasks efficiently to meet
- Proficient knowledge of medical terminology.
- Expertise with GCPs and regulatory compliance guidelines for
- 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
Keywords: Global Kinetics Corporation, Saint Cloud , Clinical Project Manager, Executive , Saint Cloud, Minnesota
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