EDC Programmer
Palo Alto, CA 
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Posted 13 days ago
Job Description
OVERVIEW
We are currently searching for a skilled professional to join our client's team in Palo Alto, California as an EDC Programmer. This remote role will collaborate with Data Management across the life cycle of study start-up through database modifications and provide technical support on core business packages including iMedidata, Classic Rave, Rave EDC, BO4, and supplemental packages. Apply now to talk to one of our recruiters and learn more about this progressive career opportunity.

RESPONSIBILITIES
  • Design, create, update, and test clinical databases including eCRF's, folders, matrices, data dictionaries/code lists, unit dictionaries, edit checks/rules, derivations, custom functions, standard, and custom reports
  • Comply with data standards aligned with industry standards (e.g., CDISC) and regulatory guidance
  • Create metric reports and data listings
  • Ensure appropriate methods are used for reporting (i.e. SAS, BO4, Jreview, etc.), metrics, and analytics
  • Participate in UAT and validation tasks related to EDC and build with strong attention to detail/timelines
  • Track and provide archival activities
  • Assist vendors holding Client's additional Rave URLs
  • Support post-production system modifications
  • Perform system integration activities, application updates, and user acceptance testing

EXPERIENCE
  • Minimum of 8 years of clinical database/EDC programming experience required
  • Knowledge about clinical database/EDC systems (ex. Medidata Rave, Veeva EDC, Oracle InForm, Medrio, etc.)
  • Minimum of 5 years of consecutive experience programming in different EDC platforms
  • Minimum of 3 years of custom function programming experience preferred
  • Working knowledge of FDA Guidance Documents: FDA/ICH guidelines, Computerized Systems Used in Clinical Trials, and Software Validation
  • Strong knowledge of 21 C.F.R. Part 11 and CDISC Standards (CDASH, SDTM, and the creation of data mapping specifications and annotated CRFs)
  • Experience with Medidata Coder, Lab Administration, and Automated Serious Adverse Event reporting modalities (Rave Safety Gateway)
  • Advanced experience using SAS and SQL, C#, Crystal Reports, Business Objects, BO4, and other business intelligence tools required
  • Experience with reporting tools such as J-Review, Spotfire, and/or Cognos
  • Strong problem-solving and organizational skills required
  • Excellent written and verbal communication skills

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.

It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
8+ years
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