CDM Systems Specialist
Category: Clinical
Job ID: R-19790
Location: United Kingdom – Cambridgeshire
Posted Date: June 1, 2016
Title: CDM Systems Specialist
The company:
Amgen is one of the world’s largest independent biotechnology companies, with global revenue in excess of $18 billion and over 18,000 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, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.
The Role:
This position will partner with Electronic Data Capture (EDC) vendor and cross functional teams in providing premier EDC platform (Medidata Rave), EDC integrations and study level EDC support for Amgen’s clinical trials conducted within the Global Development Operations (GDO).
Primary Responsibilities:
Partner with the EDC Vendor Medidata to deliver customized study-level solutions or complex fixes
Provide study-level support for established EDC-integrated capabilities during study start-up, conduct and closeout (e.g. study-level eSAE integration support)
Maintain overall health of EDC platform by balancing study-level system activities
Partner with the EDC Vendor Medidata to deliver an up-to-date, scalable and high performance EDC platform
Oversee or support EDC security and account management
Lead or deliver new EDC capabilities or system integrations
Lead or deliver new robust EDC data sharing mechanisms for GDO clinical ecosystem
Lead or deliver innovative technical solutions in support of continuous process improvement projects
Build effective relationships and partnerships within GDO, IS, Global Statistical Programming, Global Safety, Compliance, Quality Assurance, and other key stakeholders and functional service providers
Leadership Skills:
The EDC Operations Specialist 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 specialist 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 will have an in-depth technical knowledge in order to lead technical projects, 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.
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 either working and or leading a technical team with strong 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 an FSP, ensure operational experience with clinical database management systems (preferably 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: Cambridge or Uxbridge
Basic Qualifications
Relevant Bachelors or Masters degree
Demonstrated Clinical experience
Preferred Qualifications:
Bachelors degree or equivalent in life science, computer science, business administration or related discipline
Extensive experience in life sciences or a medically related field
Demonstrated experience in a technical role within clinical data management, clinical development, or IS/IT
Extensive hands-on operational experience and system knowledge of Medidata Rave and/or other Medidata products such as i-Medidata, Safety Gateway, Batch Uploader, Coder etc
Work experience integrating other clinical technologies including but not limited to IVRS, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry
Strong project management 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 teams 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
Remuneration: Competitive salary and benefits package
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