Amgen

Manager CDM Systems

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Mar 22, 2019
Ref
R-70285
Required Education
Bachelors Degree
Position Type
Full time
The Manager CDM Systems will partner with the Electronic Data Capture (EDC) vendor and cross functional study teams in providing premier study level support as EDC integration expert for Amgen's clinical trials conducted on Rave EDC platform within the Global Development Operations (GDO).

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.

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, be able to address conflict head-on and facilitate rapid resolution to issues.

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. Represent Amgen's business 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.

Responsibilities:

• 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)

• Partner with clinical study team and EDC provider to gather business and technical requirements and develop customized study-level solutions as needed

• Maintain overall health of EDC platform by balancing study-level system activities

• Support ad-hoc Rave EDC data generation requests via complex SQL programming; i.e. familiar with Rave EDC backend database schema

• Partner with the EDC Platform Team to deliver an up-to-date, scalable and high-performance EDC platform; include EDC platform upgrades etc

• Lead or support new EDC capabilities or clinical system integrations

• Lead or support new robust Rave EDC data sharing mechanisms (API, webservices, flat files) within internal technical ecosystem

• Lead or deliver innovative and emerging technical solutions within the clinical trial landscape (i.e. Webservices, eSource, mHealth etc)

• 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)

Basic Qualifications:

Doctorate degree
OR
Master's degree and 3 years of biopharmaceutical clinical research experience
OR
Bachelor's degree and 5 years of biopharmaceutical clinical research experience
OR
Associate's degree and 10 years of biopharmaceutical clinical research experience
OR
High school diploma / GED and 12 years of biopharmaceutical clinical research experience

Preferred Qualifications:

Extensive hands-on operational experience working in Medidata Rave EDC and Rave Safety Gateway (RSG).

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 IVRS, 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 needs

Sound problem resolution, judgment, and decision-making abilities

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

Amgen is committed to unlocking the potential of biology 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.