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Associate Director, Clinical Operations

Cambridge, MA

Posted: 09/06/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2352

The Associate Director of Clinical Operations is responsible for assisting in all aspects of clinical development programs, reporting to the Sr. Director of Clinical Operations. Shared responsibility for all aspects of Phase 1-3 development including the direction, planning, execution, and interpretation of clinical trials under Good Clinical Practices.  Assist in development and implementation of strategy, policies, and procedures.  Manage some aspects of external vendor contracts including CRO.

KEY RESPONSIBILITIES:
  • Establish clinical development plans and report generation to track progress in meeting key milestones.
  • Interact with program management and key functional groups about issues affecting clinical programs including timelines and communications of data.
  • Work with internal and external stakeholders to ensure completeness, accuracy and validity of data.
  • Assist clinical trial managers in the planning, designing and managing progress of clinical projects.
  • Assist in some management responsibilities for the clinical team including, but not limited to hiring, and developing, training; contribute to management of clinical team to ensure a high level of performance.
  • Assist Sr. Director with Clinical Trial Material (CTM) planning, SOPs, templates, forms and systems for contracts, budgets and clinical trial agreements, etc.
  • Remain current and gain working knowledge of the product and relevant clinical indication(s) by establishing working relationship with appropriate internal personnel and outside experts.
  • Responsible for assuring compliance with internal SOPs, FDA regulations and GCP regarding reporting of adverse events to regulatory agencies.
  • Participate in request and review of scope of work, budgets, vendor performance and issue resolution.
  • In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents.
  • Manage clinical trial budgets, providing ongoing financial reporting and projections to finance group.
  • Responsible for creation and management of program-level budget(s) with Program Lead.
  • Participate in contract and budget negotiations with CROs, clinical sites and vendors.
  • Work cross-functionally to ensure clinical program timelines and goals are met
  • Provide study-specific mentoring and line management for junior team members, as appropriate.
  • Assume leadership role in operational improvement initiatives (e.g. SOP development, training etc.).

REQUIREMENTS / QUALIFICATIONS:
  • Bachelor’ s degree in health sciences or related field.
  • Minimum 10+ years of clinical operations and 3+ years management experience in an industry setting.
  • Experience in Oncology is preferred and experience with data management will be favorably considered.
  • Comprehensive knowledge of clinical development processes (Phase 1-3), policies, and regulations.
  • Extensive CRO/vendor management experience required.
  • Strong management experience including employee development and team building.
  • Proficient written and verbal communication skills.
  • Excellent leadership, interpersonal, communication, planning and organizational skills required.
  • Established ability to manage and demonstrated ability to identify and resolve issues.
  • Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues.
  • Ability to function at a high level in a team setting.
  • Maximum flexibility to adapt to changing program needs in real time.

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.

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