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Clinical Operations Lead

Cambridge, MA

Posted: 01/20/2021 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2699

Job Description


The Clinical Operations Lead will oversee clinical trial execution to ensure compliance with regulatory requirements, adequacy of data acquisition and management, and timely completion of clinical studies.

Responsibilities:
  • Implement all logistics associated with execution of clinical studies and provide daily oversight of operations
  • Contribute to design and review of clinical trial documents and plans, regulatory submissions, and reports
  • Contribute to identification, evaluation and selection of investigators, sites, and vendors
  • Serve as the primary point of contact and provide guidance for project specific CROs and vendors
  • Expedite problem identification and resolution to ensure timely completion of clinical trials
  • Review and provide guidance as needed on monitoring reports from CROs to ensure applicable regulatory and protocol compliance, issue resolution, and quality site management and reporting
  • Ensure eTMF is current throughout the conduct of assigned clinical trials
  • Lead strategies for patient recruitment and retention in clinical trials
  • Monitor, communicate, and manage budgets for clinical trials
  • Travel is required (approximately 30%)

Requirements / Qualifications:
  • Bachelor’ s degree required
  • 6-8+ years of clinical trial management, with a focus on leading oncology programs
  • Early-phase clinical trial experience, including IND submission, site start-up activities, and ongoing trial management
  • Vendor management experience a plus
  • Deep knowledge of GCP, ICH, and FDA guidelines
  • Experience in CSR preparation and Health Authority interactions
  • Experience selecting, managing, troubleshooting, and negotiating with CRO vendors
  • Computer proficiency (Microsoft Office suite, Microsoft Project, and expertise with current electronic patient-tracking systems)
  • Strong project management and interpersonal skills
  • Excellent written and oral communication skills

The Ideal Candidate:
  • Has extensive experience leading oncology clinical programs
  • Has strong communication skills, with the ability to work in a fast-paced and team-oriented environment
  • Is a motivated leader with a passion for bringing new treatments to patients
  • Is excited by a lean and changing organization, with the opportunity to provide input into non-project related activities
  • Enjoys a transparent, outcome-oriented, respectful, and innovative environment

Meet Your Recruiter

Tracey Goldthwaite
Senior Vice President

Tracey spearheads the firm’s Commercial practice and focuses on identifying and placing individuals in leadership roles within Global Marketing, Medical Affairs, New Product Planning, and Patient Advocacy and Engagement, to name a few. With 25 years of experience, she also plays a key role in the Clinical Staffing practice, recruiting top talent of all levels for positions in our core areas including Clinical Operations and Development, Regulatory Affairs, Pharmacovigilance and Program Management.

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