Sr. Manager Clinical Application & Standards - (Gaithersburg, MD) - Gaithersburg, MD | Biospace
Get Our FREE Industry eNewsletter

Sr. Manager Clinical Application & Standards - (Gaithersburg, MD)

MedImmune, LLC

Gaithersburg, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Gaithersburg, Maryland, United States
Job reference: R-006642
Posted date: May. 09, 2017

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  As a Sr. Manager Clinical Application & Standards in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Main Duties and Responsibilities

As the  Sr. Manager Clinical Application & Standards, you will manage and accountable for the Data Management Clinical Database Development and Database Standards group and serves as the escalation point to resolve any relevant issues in the group. Develop and maintain the database capabilities along with relevant functionality in the Database, Standards &Data Acquisition of Data Management.  You will functions as an EDC expert providing guidance and best practices to DM, Clinical teams and other stakeholders.  You will be a SME for EDC between Data Management, CRO partners, and business stakeholders responsible to address escalation of study specific functional issues, tool issues, version upgrades, patch fixes, validation/testing needs, enhancement requests, custom functions and/or custom reports.  As the Sr. Manager Clinical Application & Standards, you will contribute/support integration of different clinical systems and similar initiatives that enhance efficiencies and quality of data management processes.  Oversee the development, maintenance, and compliance of database builds and EDC standards in support of clinical studies including, but not limited to, Global Library, Edit

Checks, CRF modules and Standard/Custom Reports.  Provide expert EDC technical support to facilitate clinical study timelines and deliverables.  You will oversee the EDC Administrator role to support operational deliverables under Study Set Up, Study Maintenance, Study Conduct and Study Close Out.

Manage timely and quality deliverables to the Study Teams, Management and other

Stakeholders Supports DM initiatives that may include outsourced trials, CROs and off-shore partners


Essential Requirements

  • BA / BS Computer Science/Information Technology of Life Sciences from a 4 year accredited university or equivalent experience.
  • Clinical programming experience is required.
  • Proficient computer skills across multiple applications.
  • Minimum 8 years clinical database programming experience preferred in the device / pharmaceutical / CRO industry.
  • Minimum 4 years database programming experience designing studies and data validation programming in EDC required; RAVE/Medidata Solutions preferred.

Desirable Requirements

  • Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is required
  • Expertise with reporting tools; J-Review, SAS, and/or Spotfire are preferred
  • PL/SQL, SQL scripting experience required; understanding of relational databases.
  • Knowledge of industry standards; CDISC-SDTM/CDASH preferred
  • Experience with external data handling of study data preferred
  • Experience with clinical dictionaries; Thesaurus Management System (TMS), MedDRA and
  • WHO dictionaries are preferred
  • Proficient understanding of system administration to effectively interact with the tools and/or
  • database administrators

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.