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Clinical Database Developer / Clinical Data Manager

CardiacAssist, Inc. • Philadelphia, PA
2 months ago

Join us today and make a difference in people's lives!
 

We are seeking an experienced Clinical Database Developer who has also led clinical studies as a Clinical Data Manager, someone who can create and maintain database infrastructure for the collection of our clinical data. You will be responsible for the design, implementation, and validation of databases, edit checks, and import/export of external data. You will lead two or more studies at any given time. You are responsible for defining, developing and maintaining all database development activities, from start-up to database lock, across multiple global clinical trials while ensuring quality and compliance standards are aligned with applicable regulations, Good Clinical Data Management Practices, and LivaNova standard operating procedures. If you are currently looking to develop and grow your career, this will give you the opportunity to do that.

Responsibilities

  • Responsible for planning and executing clinical database infrastructure activities in clinical studies.

  • Develop and maintain trial specific database applications, including eCRFs and database specifications.

  • Program validation and derivation procedures within the clinical database management system (such as IBM Clinical Development) using relevant programming languages (SQL, PL/SQL, C #, VB script, SAS) in support of in-house and outsourced trials globally, of various levels of complexity

  • Develop the eCRF layout and corresponding database according to documented trial-specific requirements using components from existing libraries

  • Provide data transfer specifications for third party data

  • Create, file, and maintain appropriate trial documentation

  • Create and execute trial design reports based on trial metadata

  • Works to provide expertise in the development and maintenance of database development standard operating procedures and best practices

  • Partner with clinical data systems vendors in keeping abreast of technology trends and applicability to Statistics & Data Management needs

  • Ensures that all activities under responsibility are properly documented (traceability of changes, data specifications) according to the internal guidance documents

  • Keeps abreast and look for opportunities for applying innovative database infrastructure management methods and enhancements.

  • Reviews/contributes to project management plan of clinical activities and ensure that deadlines are met.

  • Collaborates effectively with Statistics & Data Management internal and external partners in all activities where handling and reviewing of clinical data is needed.

  • Works according to ICH-GCP, other international guidelines (e.g., ISO), working group recommendations (e.g., CDISC or Good Clinical Data Management Practices) as well as internal quality system.

The top 3 must haves for you to be able to be successful in this role will be:

  • Solid EDC (electronic data capture) experience: defining, developing, and programming eCRFs, edit checks, notifications, data imports, and dataset structure. Looking for a junior database developer (developed 10+ EDC study builds, more or less).

  • Good understanding of what is needed to bring EDC in-house. Needs to be able to define, develop, and implement the SOPs, processes, and tools needed for EDC in-house.

  • Strong understanding of CDISC compliant databases. Needs to have participated in defining or maintaining a CDISC compliant eCRF library and defining data variables using CDISC models.

Requirements

  • Bachelor''s degree, life sciences field is preferred.

  • Minimum of two years’ industry related database programming experience with industry standard EDC databases and clinical data management team experience during study start-up, conduct, and database lock phases in the medical device, pharmaceutical, or CRO industry.

  • Technical expertise in understanding and implementing clinical data management methods along with experience in the design, build, and validation of EDC platforms and a clinical understanding of medical terminology and adverse event reporting.

  • Knowledge of data structure standards (CDASH, SDTM).

  • Ability to understand how Windows scripts work, SQL, and API connections is preferred.

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Our commitment to Diversity & Inclusion:

LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.

Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Background Checks at LivaNova:

Upon successful completion of the hiring process an offer may be extended. Please note, LivaNova reserves the right to conduct background investigations and/or reference checks on all its potential employees, where permitted by local legislation. This offer therefore, is contingent upon a clearance of such a background investigation and/or reference check, and can be rescinded, where permitted by local legislation, based upon data received in the background check and/or refusal to cooperate with or any attempt to affect the results of this check. This process is not currently valid in Germany.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.