Associate Director, Clinical Operations

Boston - Massachusetts - United States - Life Sciences & Health Care - Pharmaceutical - Clinical - Academic Master

  • Our client who is a clinical-stage oncology company is seeking an Associate Director of Clinical Operations as they grow the team in Boston Massachusetts.

Feel free to contact

Diana Grodowski, Account manager

Apply now

About this role

  • The Associate Director of Clinical Operations is accountable for the operational strategic planning, oversight and successful delivery for one or more clinical programs.
  • The Associate Director may lead or sponsor Clinical Operations organizational initiatives;
  • The core duties and responsibilities of the Associate Director include, but are not limited to;

Responsibilities:

  • Provide operational and implementation expertise to the company project teams to enable timely progression of clinical development programs;
  • Clinical trial operational lead for clinical development program ensuring successful planning, implementation and conduct of all assigned clinical trials;
  • Oversight and management of CRO to ensure timelines of clinical development plans are met;
  • Work with the project team to identify and evaluate issues in the program, interpret data on complex issues and suggest and implement solutions;
  • Participate in design and development of clinical trial protocols;
  • Provide oversight for development of specific study documents (informed consent forms, study guidelines, operation manuals & training materials;
  • Contribute and assist with the development of the clinical components of regulatory submissions;
  • Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites;
  • Oversee and manage clinical development program budget;
  • Work on complex program issues in which analysis of situations or data require an in-depth evaluation of various factors;
  • Ensure that goals and objectives for clinical development programs are met by providing strategic and tactical input by developing program specific goals, tracking metrics, producing and presenting summary reports;
  • Prepare and present clinical development trial updates to project teams and management and review any potential issues or recommendations;
  • Evaluate site and study performance metrics against agreed upon budget, deliverables and timelines;
  • Contribute to and review clinical documents such as protocols, trial reports and SOPs consistent with GCPs and other applicable government and regulatory standards;
  • Lead and mentor others in Clinical Operations.

About you

Qualifications:

  • BA/BS in a scientific field of study with 10+ years of relevant experience working in in the pharmaceutical/ biotech industry;
  • Oncology Experience Required;
  • In-depth understanding of industry standards and applicable guidelines; FDA regulations and ICH GCP knowledge;
  • Experience in developing Clinical Operations SOPs and metrics;
  • Proven leadership experience with the desire and ability to work in a fast-paced, matrixed, start-up environment;
  • Strong collaboration and team-working, communication and organizational skills required;
  • Strong problem solving and analytical skills necessary;
  • Ability to prioritize and manage time demand, incomplete information, and unexpected events;
  • Willing to travel domestically and internationally.

What we offer

What we offer

  • Why apply through Brunel?
    Finding the next step in your career can be a fulltime job in itself;
  • We manage
    the process for you: from submitting your resume to coordinating interviews to
    extending offers and assisting with on-boarding;
  • We’ll get you going while you
    get on with the job.

About us

About us

  • Brunel has a reputation for working with some of the best in the business;
  • That’s what we continually strive for;
  • Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services;
  • Join us today.

Summary

  • Publication: PUB293955
  • Location: Boston
  • Market: Life Sciences & Health Care
  • Hours per week: 40
  • Branche: Pharmaceutical
  • Education level: Academic Master
  • Area of expertise: Clinical
  • Closing date: Thursday, April 1, 2021
Apply now

Feel free to contact

DG

Diana Grodowski

Account manager Brunel Canada - Toronto

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