Associate Director, Clinical Data Standards

Proclinical is currently recruiting for an Associate Director of Clinical Data Standards with a global pharmaceutical company located in Boston, MA. Successful candidate will be responsible for leading and conducting the development, deployment, management and governance of clinical standards needed to support drug development processes as well as supporting standards initiatives and CROs/strategic service provider interactions.

Job Responsibilities:

• Responsible in an individual contributor role that requires project management leadership of standards projects and the ability to partner closely with internal/external standards stakeholders in a collaborative manner.
• May be responsible for leading the identification, review/evaluation, deployment and usage of technologies to generate, distribute, integrate with and report on standards compliance internally and collaboratively with CROs/strategic service providers.
• Build relationships across the global organization and with CROs/strategic service providers in support of the standards vision and implementation.
• Establish and maintain project plans and effectively articulates them; define risks and recommend contingency plans.
• Own, govern and maintain designated GDO developed standards models (including but not limited to: CDASH, SDTM, Controlled Terminology, ADaM, TFLs and questionnaires). Includes periodic assessment of standards content with respect to compliance and industry impacts.
• Lead assessment, implementation, integration and governance of systems and tools to support, manage, govern, and report on standards.
• Lead the assessment of applications used for standards metadata management such as the Standards Knowledge Base.
• Lead the assessment of updates and/or suggested enhancements to the standards library, standards knowledgebase/governance portal, Pinacle21 and other applications. Coordinate with IT where necessary.
• Contribute to the GDO metadata standards management strategy and leads associated projects or initiatives.
• Ensure timely communication of new and/or revised standards.

Skills and Requirements:

• BS degree in Scientific or related field is preferred.
• 8-10+ years in Data Standards or Data Management or Programming or Statistics.
• Strong working knowledge of CDASH, SDTM or ADaM, and CDISC controlled Terminology.
• Knowledge of XML preferred.
• Experience with leading teams and/or organizations. Demonstrated knowledge of drug development process.
• Demonstrated knowledge of regulatory guidances, requirements and industry standard practices as pertaining to clinical data standards and metadata management.
• Strong attention to detail and accuracy is a must.
• Ability to read, analyze and interpret complex technical documents and to present complex issues in oral and written form.
• Ability to think strategically and to develop new approaches and processes.
• Ability to facilitate discussions and share knowledge across multiple study teams, functional lines and management levels.
• Ability to work independently, take initiative and complete tasks to deadlines.
• Knowledge of at least one data management system and/or working knowledge of SAS.
• Must have an understanding of database concepts.
• Strong working knowledge of clinical trial terminology and concepts preferred.
• Proven ability to manage and communicate effectively with service providers including Budgeting, forecasting, negotiating contracts, reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints.
• Demonstrated ability to lead projects and work groups. Strong project management skills.
• Proven ability to independently and collaboratively resolve problems.
• Must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple competing tasks and demands.
• Ability to work independently, take initiative and complete tasks to deadlines.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Felix Hook at (+1) 646-367-2617 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-FH2

#Biometrics

#ClinicalResearch