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1+ months

Clinical Program Manager

Kelly Services
Raleigh, NC 27608
Kelly is currently seeking a Clinical Program Manager with Medical Device experience for a long-term engagement at one of our Global clients.


This role is a full-time, offering our enhanced benefit package options. As a Kelly employee within this group, you will be eligible for Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise. All KellyOCG employees receive annual performance reviews.


**SUMMARY**


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


**RESPONSIBILITIES**


Under general direction and in accordance with all applicable federal, state and local laws/regulations, 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

+ May serve as the primary contact for clinical trial sites (e.g. site management);

+ Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal supervision;

+ Ensure applicable trial registration from study initiation through posting of results and support publications as needed; (e.g. on www.clinicaltrials.gov )

+ Management/oversight of ordering, tracking, and accountability of investigational products and trial materials;

+ Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel;

+ Oversee the development and execution of Investigator agreements and trial payments;

+ Responsible for clinical data review to prepare data for statistical analyses and publications;

+ If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;

+ May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects

+ 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;

+ May serve as the clinical representative on a New Product Development team;

+ May be responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports;

+ May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging;

+ Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;

+ Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency;

+ 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.


**Education**


+ Minimum of a Bachelors Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.


**Experience**


+ 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.


**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;

+ Strong presentation and technical writing skills;

+ Strong written and oral communication skills;


**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsorship now or in the near future.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-20 Expires: 2021-11-20

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Clinical Program Manager

Kelly Services
Raleigh, NC 27608

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