Manager, Data Management

San Francisco, CA

Perm Salary

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OVERVIEW

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

RESPONSIBILITIES

  • Responsible for overseeing all Data Management operational activities ensuring compliance with the corporate timeline and scope of work outsourced to the Data Management service provider and coordinating activities from other external vendors that may also provide study data 
  • This includes but is not limited to vendor and technology evaluation, qualification and selection, budget assessment and contract negotiations, training and oversight for all DM services from study start-up through study close-out and final reporting  
  • Participate in vendor and technology evaluation, qualification and selection. Involved in RFP development and contract negotiation, as needed
  • Oversee and manage all Data Management related activities outsourced to service provider as well as other external data sources from study start-up through study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time and within budget 
  • Participate with the Study Operations Teams for all study activities, and lead all DM functional activities using templates and processes as applicable
  • Provide operational leadership to the direction, planning, execution, collection and handling of all clinical data to the highest quality standards while ensuring established standards
  • Review study data for completeness and general clinical sense  
  • Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns
  • Develop and manage the data review plan for each assigned study, including maintenance and tracking of findings from all team members through issue resolution and involving the data vendors as needed

EXPERIENCE

  • Minimum seven years of relevant clinical experience in the pharmaceutical, biotech and/or CRO industries, or equivalent
  • Skills present in core data management activities 
  • CCDM Certification a plus
  • Knowledge and experience with various clinical databases 
  • Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required
  • Excellent communication, written and interpersonal skills
  • Self-sufficient and able to work with minimal oversight
  • Demonstrate leadership skills and the ability to lead teams and motivate team members, as needed
  • Able to prioritize and handle multiple tasks and studies simultaneously
  • Able to manage direct staff, as needed. Ability to develop project management objectives and manage performance reviews, as needed
  • Proficiency with MS Word, Excel, Outlook, and PowerPoint, SAS programming a plus
  • Must be willing to travel as required

EDUCATION

  • Bachelor’s degree in a relevant scientific discipline or equivalent

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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