• Posted on: May 26, 2022
  • Location: Woburn, MA
  • Job ID: 9e66e9f0
  • Type: Full Time
  • Category: Operations
  • Posted on: May 26, 2022
  • Location: Woburn, MA
  • Job ID: 9e66e9f0
  • Type: Full Time
  • Category: Operations

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Job Description: Head of Clinical Operations

We successfully completed our first clinical study in Autism and moving forward with the next phase of development which created the opportunity for an enthusiastic and energetic Clinical Operations professional to join our growing team in preparing and driving the next phase in these therapeutic areas.  To be successful in this role, you need to be someone who shares our passions, commitment to patients and can thrive in the fast-paced environment of a small growing biotech company.

Your Role:

  • Responsible for the setup, development, and management of global clinical trial programs and simultaneous clinical studies from concept through clinical study report completion and ensures that all aspects of the study are conducted in accordance with all applicable regulations and internal SOPs to support business strategic initiatives.
  • Review and provide input to clinical protocols for feasibility of clinical trial conduct; identify potential risks and obstacles and identifies opportunities for accelerating the delivery of those studies.
  • Lead the development of, and ensures adherence to clinical study plans (quality, vendor management and oversight, data management, site monitoring, TMF quality control, and study communication plans).
  • Act as the main study focal point, establish and maintain key strategic relationships with service providers, networks of clinicians, and internal partners for effective roll-out of the trials.
  • Develop, track, and ensure that clinical trial programs meet timelines and study budget while ensuring patient safety and data quality.
  • Support and contribute to the ongoing improvement and review of clinical and regulatory documentation and processes for the group.
  • Plan and manage multi-center, multi-national clinical trials including management of relationships with clinical sites and oversight of their activities; work with Clinical Operations Management and QA to resolve issues or problems with/at the sites.
  • Develop study-specific strategies and execute plans that ensure robust patient enrollment.
  • Proactively alert Senior Management and QA to risks/challenges and provides appropriate solutions to mitigate them in collaboration with QA.
  • Support the development of protocols, informed consent forms, investigational plans, and study materials (e.g., training materials, case report forms, Pharmacy Manual, Trial Master Files, Clinical supplies). 
  • Support regulatory filings and submissions, as necessary.
  • Provide input on and/or lead departmental initiatives and goals aimed at enhancing the capabilities of our Clinical Operations team.
  • Participate in cross-functional teams to achieve clinical program objectives within the broader context of our business goals and future expansion.

 

Education & Experience Requirements

  • Minimum of bachelor’s degree or equivalent in scientific, nursing, or medical discipline.
  • Minimum of 7+ years of Clinical Operations experience
  • Patient-focused and quality mindset
  • Demonstrates thorough knowledge and understanding of key regulatory requirements, relevant ICH Guidelines including cGCP.
  • Experience in communicating protocol requirements clearly and concisely to all key participants in trials.
  • Proven ability to proactively identify, mitigate and resolve program risks.
  • Proven ability to work collaboratively with multifunctional teams and relentless in pursuing successful outcomes.
  • Experience in using EDC, CTMS, and TMF systems
  • Experience working in a neurodegenerative disease or neurodevelopmental disorder therapeutic areas strongly preferred.

Key Skills and Competencies

  • Ability to manage complex programs and clinical trials independently with limited supervision.
  • Strong verbal, written and presentation skills.
  • Demonstrable advanced knowledge of relevant software packages (e.g., Microsoft Project, Word, Excel, PowerPoint).
  • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
  • Flexibility in working hours and readiness to travel.
  • Thrives in a fast paced, multi-tasking, startup environment.

 

 

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