Search Jobs

Your NEXT GREAT OPPORTUNITY is within reach!

Clinical Project Manager

Chicago, IL

Posted: 10/10/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2390

Reporting to the Vice President, Clinical Development, the Clinical Project Manager will be responsible for the planning and management of the operational aspects of clinical trials, including CRO and vendor selection and management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are consistent with program/company goals.

Responsibilities include:
  • Collaborate with internal and external team members for the planning and execution of clinical trials.
  • Lead/oversee operational activities to ensure deliverables are prioritized and goals and objectives are met and/or changed accordingly.
  • Assist with development and management of project timelines and budgets; help ensure project deliverables are on time and within agreed upon budget and amended accordingly
  • Ensure clinical trials meet time, quality and cost targets consistent with the overall Clinical Development Plan.
  • Lead the development of and provide input into study-related documents, including clinical protocols, ICFs, CRFs, monitoring plans, study, lab and pharmacy manuals, data management plans, etc.
  • Contribute to department process development, such as the development and writing of Standard Operating Procedures (SOPs).
  • Collaborate with legal and finance (and others, as needed) on the development and management of study specific agreements (i.e. non-disclosure agreements, clinical trial agreements, clinical research organization agreements, payment terms, etc.)
  • Oversee the conduct of studies and ensure studies are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures.
  • Monitor clinical study site activities and visit sites as needed
  • Track, collect, and review clinical documentation for clinical trials or ensure this is being done by CRO or internal staff.
  • Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.

Requirements / Qualifications:
  • Minimum BA/BS degree in a science/healthcare field, a nursing degree, or equivalent combined education.
  • At least 5 years of Clinical Trial Management/Clinical Operations experience required. Experience in endocrinology preferred.
  • Must have experience in CRO oversight.
  • Excellent Leadership skills; ability to collaborate across disciplines.
  • Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.
  • Ability to manage multiple projects and resources.
  • Ability to effectively communicate, both verbally and in writing.
  • Ability to work independently, and be self-motivated and self-disciplined
  • Some domestic travel required (up to 25%).

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

Apply Online
Apply with LinkedIn Apply with Facebook Apply with Twitter

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.