Clinical Study Manager

Boston, MA

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Clinical Study Manager in Boston, Massachusetts.  The Clinical Study Manager role will serve as operational leadership for assigned trials, as they provide overall coordination and management of clinical trials from start-up to close-out. The Clinical Study Manager will also act as liaison with other functional areas to identify issues, evaluate situations, and make sound business decisions to ensure implementation of timely solutions. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity!

RESPONSIBILITIES

  • Identify and select high-quality clinical vendors in conjunction with the appropriate team members 
  • Work with the contracting/budgeting team to ensure that vendor responsibilities and payment terms are clearly defined
  • Manage and provide oversight of assigned clinical vendors and functional service providers to ensure data integrity and adherence with regulatory requirements
  • Assure that team is receiving high quality, on time deliverables from internal and external vendors
  • Collaborate with other team members to coordinate the development and finalization of key study documents (including protocols, case reports forms, informed consent documents, study management plans and final clinical study reports)
  • Work with finance manager on financial aspects of the project(s), including milestone payments, and monthly pass through invoices 
  • Assume co-monitoring responsibilities as needed 
  • Communicate with Principle Investigator, Study Co-Coordinator, and/ CRO (if applicable) to proactively recognize problem situations and work with other team members as required to resolve issues

EXPERIENCE

  • Minimum 5 years of experience in Clinical Trial Management
  • Knowledge of overall clinical drug development and general clinical research operations in the Pharmaceutical or Biotech industry
  • Experience in providing operational leadership for assigned trials executing them on time and within budget, and overall coordination and management of clinical trials from startup to closeout. As well as liaise with other functional areas to identify issues, evaluate and make sound business decisions and ensure implementation of timely solutions

EDUCATION

  • Bachelor’s Degree, preferably in biological science, nursing, or other related field
  • Advanced Degree preferred
  • Training in the following subjects is required: Applicable Standard Operating Procedures, Good Clinical Practices (i.e. GxP Regulations; ICH Guidelines; Good Quality Practices), 21 CFR Part 11 and Computer Security, HIPAA, Drug Development and Approval Process, Data Management Overview, Sponsor/Study specific trainings, and Applicable System training 

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.

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