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Manager, Clinical Programming

Job Location: PA - Berwyn

Job Number: 00448328

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- Job description

Join Accenture and help transform leading organizations and communities around the world.  The sheer scale of our capabilities and client engagements and the way we collaborate, operate and deliver value provides an unparalleled opportunity to grow and advance. 

 

Choose Accenture, and make delivering innovative work part of your extraordinary career.

 

Job Description

 

The Manager of Clinical Programming is responsible for the following:

  • Providing leadership in the creation and validation of SAS programs in support of sponsor s clinical trials.
  • Ensuring that the SOPs and guidelines are followed in creating the derived clinical databases and data displays to high quality and per agreed timelines.
  • Providing direction to statistical programmers, programmers, and biometricians in creating sponsor deliverables.
  • Acting as a lead programmer for regulatory submissions.
  • Directing the design, development, validation, and delivery of multiple clinical trial project deliverables, leading to regulatory submissions according to current regulations and guidance.
  • Managing internal and contract SAS programmers on a daily basis.

Basic Qualifications

  • A minimum of 10 years of programming experience, including 5 or more years of clinical SAS experience in a lead position.

Preferred Skills

  • Bachelor s Degree or Master s Degree in a related discipline or related experience
  • Previous project leader or lead programmer experience.
  • Comprehensive knowledge of the drug development process, FDA regulations pertaining to clinical programming, ICH guidelines, and the electronic submissions process mandatory.
  • Strong SAS programming and proactive problem solving skills.
  • Strong organizational, interpersonal, and communication skills.
  • Ability to constructively interact with programming teams, project management, and sponsors on a regular basis.
  • Ability to insure adherence to good clinical and programming practices and maintain exceptional quality standards.
  • Ability to manage resources, timelines, and workflow in a fast paced environment mandatory.
  • Extensive knowledge of SAS programming, SDTM, ADaM, FDA, and ICH guidance.
  • Good understanding of clinical data and pharmaceutical development.

Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Accenture (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).

Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.

Accenture is a Federal Contractor and an EEO and Affirmative Action Employer of Females/Minorities/Veterans/Individuals with Disabilities.

Equal Employment Opportunity
All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.

Accenture is committed to providing veteran employment opportunities to our service men and women.

 

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