Senior Data Management Project Manager

Fremont, CA

Contract

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OVERVIEW

Our client is looking for a highly qualified and skilled professional for the role of Senior Data Management Project Manager in Fremont, CA.  The Senior Data Management Project Manager will be responsible for reviewing study protocols and assist site coordinators, investigators, and field clinical staff in collecting data to meet the protocol requirements in a timely manner.
 
RESPONSIBILITIES
  • Will work collaboratively with the clinical project team staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
  • Ensures completeness, correctness and consistency of clinical data and data structure
  • Ensuring effective communication with vendors creating a general understanding and expectation in terms of study timelines and milestones
  • Implement the data management portions of clinical research projects
  • Identify, track, and resolve queries. Utilize reports to track study progress and ensure timeliness and quality expectations are met
  • Provide data management expertise and support project teams for assigned projects
  • Support DM Project Manager in Electronic Data Capture (EDC) systems creation, testing, release and maintenance
  • Contribute to writing, reviewing, and monitoring of data management documents and activities
  • Conduct ongoing data reconciliation, cleaning and documentation of the data management process
  • Support team to achieve database lock and final reporting
  • Coordinate resolution of team level data management issues
  • Assist other Data Management staff with operational tasks on other studies as appropriate
  • Coordinate process documentation (SOPs, Working Guidelines, etc) writing, updating and approvals
  • Perform other tasks as assigned by Director

EXPERIENCE

  • Minimum 7 years of relevant data management experience in biotech or pharmaceutical industry (CRO experience included)
  • Experience with Electronic Data Capture – Medidata Rave experience highly preferred
  • Excellent communication skills (verbal and written)
  • Ability to work independently and in team environment
  • Knowledge of FDA regulatory requirements/GCP guidance
  • Strong attention to detail

EDUCATION

  • Bachelor’s degree in Sciences (Biology, Computer/Statistics, etc.) Life Sciences preferred

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 applica

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