Clinical Outsourcing Manager

Lexington, MA

Contract To Perm

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OVERVIEW

Our client needs a Clinical Outsourcing Manager who sees the world differently. We’re looking for a professional with a minimum of five (5) years of experience who doesn’t see obstacles but opportunity when it comes to the drug development industry. The Clinical Research Associate position is a full-time contract role with the possibility to become permanent and is located in Boston, Massachusetts. We’re looking for problem solvers, innovators and those inspired by the work we do in making a difference today and with future generations. 

RESPONSIBILITIES

  • Support strategic outsourcing strategy of Clinical Development with implementation and management of outsourcing model
  • Facilitate Clinical Development Operations requests for services and contracting with CRO partner(s), Central Laboratories and other clinical suppliers 
  • Support the management of clinical suppliers and the Clinical Development partnership and onboarding of new partnerships 
  • Educate internal teams on key contractual terms and obligations
  • Proactively track issues though resolution and support their appropriate reporting 
  • Maintain knowledge base of the partnership(s), history and agreement obligations
  • Work closely with internal cross functional study teams and functions to implement improved outsourcing processes 
  • Interact with Finance, Legal, Quality Assurance and other key stakeholders to ensure adherence to corporate vendor engagement policies

EXPERIENCE

  • Minimum 5-7 years’ experience in clinical development or other health care related field in the pharmaceutical, biotech or device industry
  • Drug development knowledge with moderate to strong understanding of R&D functions including Pre-Clinical, Clinical, Regulatory, Safety and Compliance
  • Strong Knowledge of clinical supplier relationship management practices, contract negotiation and collaboration agreements
  • Familiarity with Project Management principles and tools

EDUCATION

  • Bachelor’s Degree required, Master’s Degree desirable

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

847-267-1176