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Clinical Data Management Associate Manager

Job Location: PA - Berwyn

Regional Description: Northeast

Job Number: 00620389

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- Job description

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 world’s 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 425,000 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.


This role resides within Accenture's Applied Life Sciences Solutions group. This group helps clients make a meaningful impact on patients’ lives by combining new science with leading-edge technology. We’re working with our clients to revolutionize how medical treatments are Discovered, Developed and Delivered.  Helping 90% of the Fortune 500 life sciences companies (including all of the Top Ten) with 15,000+ life sciences professionals in 50+ countries.


Clinical Operations services we provide:

 

  • Clinical data management services
  • CDISC based clinical data conversion services
  • Biostatistics and statistical programming services
  • Clinical data transparency and disclosure

Accenture data operations professionals leverage their domain expertise for authoring data management plans, EDC database design, data review, reconciliation and coding.


Accomplishments: 

  •  Processing and/or authoring of over 6.5 million case files
  • Over 2,000 clinical databases created
  • Over 900 clinical databases locked


Job Description

 

The Clinical Data Management Associate Manager role will monitor project timelines, report on project status, identify project resource needs, and understand contractual agreements to ensure successful completion of project objectives. The role 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) team.  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). 

 

 

Key Responsibilities

  • Serve 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.
  • 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 and/or update the Data Management Plan.
  • Identify and implement process improvements that may increase productivity or quality of the CDM 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 systems and tools.
  • Responsible for ensuring quality of  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

  • Minimum of an Associate's degree 
  • Minimum of 5 years' industry experience in clinical data management and or clinical programming
  • Minimum of 3 years' client facing experience

Preferred Skills

  • Experience in participating in all phases of a study, from start-up through database lock.
  • Experience in Coding Process, Vendor Data Process and SAE Reconciliation Process.
  • Expeience in Standards Development and Implementation.
  • Knowledge of CDISC CDASH standards a plus.
  • Experience in protocol assessment and case report form design; reviewing source data and annotated case report forms, Experience and knowledge of clinical data management systems (e.g., Rave, Medrio, Inform) 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 the clinical aspects of an NDA submission.
  • Knowledge of GCPs, ICH, and other applicable regulations.
  • Possess in-depth knowledge Microsoft Office applications.
  • 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 within established timelines.

·    Proficient in Microsoft Office applications.

·    Possess project management skills and perform tasks as required, such as, overview of staffing management, cost reviews, manage changes to scope, etc.


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.

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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