Kelly is currently seeking a Clinical Research Project Manager for a long-term engagement with one of our Global Medical Device clients. This position will be able to work remotely and be home-based.
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
This Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
DUTIES & RESPONSIBILITIES
Under general direction and in accordance with all applicable federal, state and local laws/regulations and company policies, procedures and guidelines, this position:
Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for the <insert Operating Company>
Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;
Responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
Track and manage assigned project budgets to ensure adherence to business plans;
Support clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy;
Generally manages work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but require minimal guidance for complex situations.
EXPERIENCE AND EDUCATION
Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
Previous experience in clinical research or equivalent is required.
Experience working well with cross-functional teams is required.
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
Clinical/medical background a plus.
Experience managing projects a plus.
Medical device experience highly preferred.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS
Functional and Technical Competencies:
Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
Ability to provide scientifically strategic and scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects;
Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
Leadership required in alignment with company Leadership Imperatives:
Connect – Develop strong collaborative relationships with key internal and external stakeholders.
Shape - Make recommendations for and actively participate and lead in departmental process improvement activities.
Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.
Deliver - Strive to ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance to SOPs and regulations.
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At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
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