Cambridge, MA

Director, Clinical Operations

Seniority Level

Director

Industry

Biotech/Pharma

Employment Type

Full-time

Responsible for Clinical Trials Management in a startup cancer diagnostics company. Coordinates and oversees functional team members, CROs, and vendors to successfully execute clinical studies under direction from VP of Clinical Development Operations. Responsible for performance metrics timeliness and quality of deliverables in the clinical trial.

Responsibilities

  • Oversees, leads and manages a cross-functional team of internal resources and external service providers to ensure clinical studies are conducted with the highest quality in accordance with study timelines, within budget, and in compliance with regulatory requirements.
  • Identifies, assesses, audits and manages third-party vendors, including CROs
  • Drives site selection and ensures trial sites are properly trained
  • Initiates and builds solid professional relationships with clinical site staff and CRO partners
  • Works with the CRO to ensure robust patient enrollment and retention strategies are developed and carried out effectively to ensure study enrollment and subject follow up is completed on time
  • Collaborates with the CRO and Thrive Data Management to ensure that robust ongoing data review and monitoring strategies are developed and carried out effectively, ensuring delivery of high-quality data
  • Proactively identifies and proposes mitigation strategies for study-related risks
  • Coordinates and has input on the development of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), informed consent documents, confidentiality agreements, IRB/EC submissions and responses
  • Responsible for reviewing and managing (if applicable) study related plans and processes, including Investigator agreements (CTA), risk assessment plans, monitoring plan, safety monitoring plan, lab manuals
  • Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met
  • Reviews and approves essential document packages to enable timely site activations
  • Performs site monitoring visits/co-monitoring visits as needed
  • Reviews pre-study, study initiation, interim monitoring visit and study closeout visit reports. Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates and risk mitigation strategies. Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
  • Leverages technology solutions to support clinical trial operations, oversight of vendors, early risk identification and data quality
  • Leads and/or contributes to development of standards and SOPs
  • Responsible for oversight on the maintenance of the eTMF and completeness at the end of the study; performs periodic QC of the eTMF
  • Oversees the planning and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements
  • Helps ensure that studies are “inspection ready” always

Qualifications

  • Bachelor’s degree or equivalent in health/medical related area preferred
  • 8+ years of experience in global trial management conducting Ph 1-3 clinical trials in the pharmaceutical, biotechnology, and/or diagnostics industry
  • A solid understanding of ICH, GCP guidelines, CFR, EMA, HIPAA regulations and GDPR and specifically, each step within the clinical trial process
  • Strong understanding of or experience in other functional aspects of clinical trial conduct
  • Proficient in reviewing and assessing clinical data
  • Budget forecasting and management experience
  • Demonstrated ability to lead teams and work in a fast-paced cross-functional team environment
  • Ability to prioritize tasks, assign resources in order to meet deadlines and be flexible to changing priorities
  • Proven proficiency in overseeing logistically complex studies being managed by a CRO
  • Excellent interpersonal and decision-making skills
  • Demonstrates innovation; possesses drive, energy and enthusiasm to deliver the program objectives
  • Possesses excellent planning, time management & coordination skills
  • Excellent written and verbal communication skills
Are you qualified?

Let's do this.