Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity with one of our leading clients!

Title: Clinical Affairs Manager
Location: Remote
Duration: 6 months +          
Type: W2 contract (NO C2C OR THIRD PARTY)

Overview

• We are looking for an experienced Clinical Affairs Manager to implement and oversee strategic clinical research trials and partner projects and to ensure clinical trials are conducted in accordance with all regulations.
  

• This role will be a key collaborator internally across the company’s cross-functional team and external research and development partners outlining and supporting execution of clinical projects needed to both secure regulatory approvals and expand commercial offerings.
  

• The Clinical Affairs Manager also is responsible for building and maintaining relationships with the clinical trials Investigators, strategic clinical development partners and clinical key opinion leaders (KOLs) across the healthcare ecosystem.

Responsibilities

• Assist in defining and developing clinical research strategy and clinical study protocols
  

• Lead and execute clinical research studies and programs including clinical pilot studies and clinical validation studies needed for regulatory approvals
  

• Lead IRB and contract processes for clinical research studies (US and International)
  

• Responsible for study management, including monitoring (manage external CROs when needed), CRF development, protocol training, and clinical study site relationships
  

• Assist with data analysis and study reporting for clinical research studies

Required Qualifications

• Bachelor’s Degree required; Master’s and/or Ph.D. strongly preferred
  

• Minimum of 3-5 years’ experience as a Clinical Research/ Clinical Affairs Manager,
  

• Experienced in managing clinical trials, know U.S. regulations, are proficient multitaskers, demonstrate team and customer-oriented passions
  

• Strong project management skills and experience, including managing external CROs
  

• Experience with research protocols and regulatory or governing bodies, including HIPAA and FDA regulations, IRB requirements, and Good Clinical Practices
  

• Experienced relationship builder and comfortable with KOL management
  

• Applicable professional certifications and international research experience are a plus

What we expect from you:

• Genuine desire to work in a dynamic, fast-paced environment
  

• Excellent verbal and written skills that can relate complex concepts in simple fashion
  

• A high-degree of autonomy and reliability; very detail-oriented
  

• A go-getter attitude, who takes accountability for their work
  

• Organized and efficient
  

• Deliver high-quality work on a tight schedule
  

• Team player

Additional Information

• First shift / Monday – Friday
  

• Slated for 6 months; eligible to extend, no guarantees
  

• Travel up to 20% required; domestic and international (
  

• Applicants must be legally permitted to work in the United States. Sponsorship is not available for this opportunity. OPT or H1B Visa is not being accepted at this time.

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. Please contact Taryn Carbone (taryn.carbone@kellyengineering.com) for immediate consideration.

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