Senior Clinical Data Manager

Waltham, MA

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Senior Clinical Data Manager in Waltham, MA.  Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity

RESPONSIBILITIES

  • May simultaneously act as lead Data Manager for multiple clinical trials from study start up through database lock
  • Participate in User Acceptance Testing for clinical database, randomization database and ePRO devices
  • Review study documentation to ensure appropriate quality
  • Assist with development of therapeutic area standards for Case Report Forms and Edit Checks
  • Oversee submission of documents to Trial Master File and related QC
  • Ensure study documentation is inspection ready
  • Assist Site Monitors with data entry and query resolution support
  • Review coding and SAE reports on an ongoing basis
  • Review and approve study budget and related Data Management costs
  • Work with Medical Affairs team to arrange timelines for delivery of data for posters and presentations
  • Present ongoing study updates to management
  • Manage escalation of study-related issues and communicate as appropriate with management
  • Help select and manage data related clinical trial vendors such as CROs and external laboratories, and ensure their performance is consistent with client standards
  • Oversee quality of both clinical and external data sources
  • Lead cross-functional team in ongoing data review
  • Work closely with biostatistician and programmers to ensure plans for data mapping and analysis are defined and appropriately documented
  • Oversee the authoring and management of study-related documentation (e. g. Data Management Plan, external vendor handling guidelines, Case Report Form Completion Guidelines, Coding Plan, etc.)
  • Assist with the development of Data Management related procedures and work instructions as necessary 
  • Monitor the status of clinical data collection and query trends
  • Assess study risks and develop risk mitigation strategy with cross-functional team members

EXPERIENCE

  • A minimum of 5 years of Data Management experience in the pharmaceutical industry with a minimum of two years’ experience in Oncology trials
  • Working knowledge of SDTM
  • Excellent verbal and written communications skills
  • Self-motivated, with strong organizational skills and attention to detail
  • Computer proficiency in MS Office (i.e. Word, Excel, PowerPoint)

EDUCATION

  • Minimum of Bachelor’s Degree Bachelor’s degree in health profession and/or science

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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