1+ months

Principal SDTM Programmer

Berwyn, PA 19312
Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions underpinned by the worlds largest delivery network Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 469,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com.

People in our Client Delivery & Operations career track drive delivery and capability excellence through the design, development and/or delivery of a solution, service, capability or offering. They grow into delivery-focused roles, and can progress within their current role, laterally or upward.

Job Description

This Principal SDTM Programmer will monitor project timelines, report on project status, identify project resource needs, and understand contractual agreements to ensure successful completion of project objectives. This person will serve as the key point of contact for the assigned projects and requires advanced skills executing all phases of a study with little supervision, as well as experience managing studies and coordinating the work of the Clinical Data Management (CDM) and/or Data Integration & Standardization (DIS) teams.

This person functions in a leadership role and must be prepared to assist the department by helping to define and achieve departmental goals as well as interface with other working groups (clinical programming, statistics).

Serves as a global team lead/project coordinator responsible for functioning as an expert in performing and/or overseeing all clinical data management activities for one or several studies and overseeing all phases of study execution from study start-up through database lock. Tasks include CRF design, creation and maintenance of a Data Management Plan, definition and validation of edit checks, involvement in database design and build, review of data entry guidelines, data review, query generation and resolution, SAE reconciliation, coding, creating and archiving study documentation.
Serves as a global team lead/project coordinator responsible for data conversion activities for a given project and function as a CDISC expert with specialization in SDTM, legacy data standards and data harmonization to support an integrated analysis.
Apply knowledge of the drug development process and the clinical trial lifecycle to create and analyze mathematical and statistical methodology in support of the development and validation of clinical trial data of various therapeutic indications.
Propose and monitor project timelines, report on project status, identify project resource needs/out of scope items, and understand contractual agreements to ensure successful completion of project objectives. This person will serve as the key point of contact for the assigned projects and is directly responsible for leading the execution of project deliverables within budgetary constraints.
Propose project strategies based on contract specifications and project timelines.
Maintain Data Conversion Plan and/or Data Management Plan.
Identify and implement process improvements that may increase productivity or quality of the CDM and DIS processes.
Work with clients to define project-specific processes and detail these processes in project specification documents.
Interact with other lines of business (LOBs) and represent Accenture at client meetings or organizations such as CDISC and/or SCDM working groups.
Assist in the selection and implementation of new CDM and/or DIS systems and tools.
Responsible for ensuring quality for internal and external deliverables; the quality of deliverables and client satisfaction are a responsibility of this role.
Mentor and train employees as well as provide input and/or deliver performance evaluations. When appropriate, heavy involvement in developing and executing training plan may be needed.
Assist in the organization of presentations at client meetings, bid defenses, internal meetings, and/or investigator meetings.
Maintain a strong working knowledge of Standard Operating Procedures, Good Clinical Practices, and Regulatory guidance applicable to project scope.
Ensure consistency in processes across a group of similar projects.

Basic Qualifications:
Bachelors degree
Minimum of 5 years' experience in clinical programming
Minimum of 5 years' experience in CDISC SDTM mapping
Minimum of 3 years' client facing experience
Preferred Qualifications:
Educational focus in Science, Math, IS, or statistics highly preferred
Experience in participating in all phases of a study, from start-up through database lock
Experience in protocol assessment and case report form design; reviewing source data and annotated case report forms; developing, reviewing, and/or utilizing database mapping specifications used to produce CDISC deliverables such as derived/analysis datasets from raw/CDMS-based datasets; and implementing programs to accomplish the mapping outlined by these specifications
Experience in completing complex data conversion jobs where multiple source variables are converted to one target variables, or one source variable is converted to multiple target variables, or jobs that relate records between different domains
Experience and knowledge of clinical data management systems (e.g., EDC) and/or data conversion/warehousing systems (e.g., SDTM), and/or associated programming languages such as SAS, SQL, and Oracle
Experience leading a team on clinical aspects of a regulatory submission
Knowledge of GCPs, ICH, and other applicable regulations
Possess project management skills and perform tasks as required, such as, overview of staffing management, cost reviews, manage changes to scope, etc.
Professional Skills Requirements:
Strong written, oral, and presentation communication skills
Must be self-motivated, highly organized, and detail oriented
Ability to identify project risks and issues and possess above average problem-solving skills
Demonstrated ability to interact with all levels of leadership team
Demonstrated ability to effectively act as a liaison between clients, internal business areas, and information services
Possess the ability to delegate and effectively manage time and resources
Ability to work well in high-pressure situations
Attention to detail and good organizational skills is a must
Ability to represent Accenture while interfacing with clients
Ability to work as part of a project team, as well as independently.
Ability to organize work and assign it to members of the study team while considering budgetary constraints and project scope
Ability to resource to established timelines
Proficient in Microsoft Office applications

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. Equal Employment Opportunity StatementAccenture is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive and more creative, which helps us better serve our clients and our communities.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.Accenture is committed to providing veteran employment opportunities to our service men and women.For details, view a copy of the Accenture Equal Opportunity and Affirmative Action Policy StatementRequesting An AccommodationAccenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.If you would like to be considered for employment opportunities with Accenture and have accommodation needs for a disability or religious observance, please call us toll free at 1 (877) 889-9009, send us an email or speak with your recruiter.Other Employment StatementsCandidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information.


Posted: 2020-09-21 Expires: 2020-11-20

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Principal SDTM Programmer

Berwyn, PA 19312

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