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EDC Technical Specialist - Clinical Systems - Uxbridge, Cambridge or possible remote working

Employer
Amgen Inc
Location
Uxbridge, London (Greater) (GB)
Salary
Competitive
Start date
25 Sep 2020
Closing date
25 Oct 2020

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Job Details

CDM Systems Manager (EDC Technical Specialist role)

Amgen EDC Operations team within Global Development Operations are looking for an experienced Technical Specialist.

If you are looking for your next career step within clinical systems operations field and want to be part of our mission – To serve patients – which drives all that we do, apply or get in touch. Take a look at our career pages to find out more about Amgen UK https://careers.amgen.com/where-we-are/en-gb/

Your EDC Operations Team:

The EDC Operations Team is responsible for enabling clinical trial operations with innovative and emergent technologies including clinical trial platform and study portfolio support as well as supporting capabilities that advances next generation of trial execution.

Your role overview:

This position (EDC Technical Specialist) will partner with the Electronic Data Capture (EDC) vendor and cross functional study teams. As the EDC integration expert for Amgen’s clinical trials, you will provide premier study level support conducted on Rave EDC platform within the Global Development Operations (GDO).

Your responsibilities:

  • You will provide study-level support for established system integration capabilities with EDC during study start-up, conduct and closeout (e.g. study-level Rave Safety Gateway (RSG) mapping between Rave EDC and Oracle Argus systems)
  • You will partner with clinical study team and EDC provider to gather business and technical requirements and develop customized study-level solutions as needed.
  • You will maintain overall health of EDC platform by balancing study-level system activities
  • You will support ad-hoc Rave EDC data generation requests via complex SQL programming; i.e. familiar with Rave EDC backend database schema
  • You will partner with the EDC Platform Team to deliver an up-to-date, scalable and high-performance EDC platform; include EDC platform upgrades etc
  • You will lead or support new EDC capabilities or clinical system integrations
  • You will lead or support new robust Rave EDC data sharing mechanisms (API, webservices, flat files) within internal technical ecosystem
  • You will lead or deliver innovative and emerging technical solutions within the clinical trial landscape (i.e. Webservices, eSource, mHealth etc)
  • You will build effective relationships and partnerships within Global Development Operations (GDO), IS, Global Statistical Programming, Global Safety, Compliance, Quality Assurance, and other key stakeholders and functional service provider (FSP)

Your qualifications and required experience:

  • Bachelors degree or equivalent in life science, computer science, business administration or related discipline
  • Extensive work experience supporting data management in the Pharmaceutical or Biotech arena
  • Considerable technical or operational experience in Rave EDC and Rave Safety Gateway (RSG)

Proven experience and skills needed:

  • Extensive hands-on operational experience working in Medidata Rave EDC and Rave Safety Gateway (RSG).
  • Must have an in-depth technical knowledge in Rave EDC, Rave Safety Gateway (RSG), Medidata Coder, iMedidata platform in order to lead fit-for-purpose technical discussions in study teams, participate in creative design sessions to resolve and/or better EDC related activities across the Amgen study portfolio or maintain other IS Supported Systems from a business requirements perspective.
  • Work experience integrating EDC with other clinical technologies including but not limited to IRT, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry
  • Strong project management and follow through skills with an attention to detail and commitment to timeline management.
  • Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study team requirements
  • Must have sound problem resolution, judgment, and decision-making abilities
  • Must be able to work well in a global team-based matrix environment with minimal supervision
  • Experience and ability creating and effectively presenting concepts and materials to senior and executive levels
  • Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary
  • Knowledge of ITIL v3 and basic Industry IS best practices
  • Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable

Leadership Skills:

  • The Manager will be a highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in a multi-project, high-pressure environment. The manager will have deep leadership experience in managing through conflict/bottlenecks, challenging inefficient practices, and possess an energetic-style to motivate fellow team members towards a common goal.
  • He or she must have a strong agility to learn new things, adapt to changes that surround the EDC ecosystem, be able to articulate a clear action or design, and collaborate (strong team player management style) with cross-functional stakeholders.
  • With strong negotiation skills, he or she will be able to address conflict head-on and facilitate rapid resolution to issues.
  • The ideal candidate will have a proven track record and experience in working in a clinical study team matrix with strong technical oversight in ensuring deliverables remain committed to goal(s) and project timeline.
  • The candidate will represent Amgen’s business requirements and needs by effective partnering and working with outsourced service delivery partners such as EDC vendor and Functional Service Provider (FSP), ensure operational experience with clinical database management systems (Medidata Rave), and have strong communication skills to maintain a high level of transparency between DM Systems centers, clinical study team members, DM business units, IS and other stakeholders.

Location: Uxbridge or Cambridge or possible remote working

Remuneration:

Competitive salary & comprehensive benefits package including bonus scheme


About our company:

Amgen is one of the world’s largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, we have invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.

Company

Amgen is committed to unlocking the potential for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.  This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.  A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

Company info
Website
Telephone
0031 (0)765786192
Location
One Amgen Center Drive
Thousand Oaks,
California
91320
GB

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