1+ months

Clinical Data Operations & Biometrics Lead

Philadelphia, PA 19133
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.

The Clinical Data Operations & Biometrics Lead is responsible for the oversight of all activities within the Clinical Data Operations and Biometrics domain. They will plan, direct, and coordinate the activities of the individual departments in order to adequately support all deliverables. This person is also responsible for establishing both departmental and individual goals and objectives and for providing leadership in defining business strategy for projects. They will be responsible for creating, implementing, and maintaining departmental processes and tools. This person will provide support for business development activities, participate in all departmental activities, ensure compliance with SOPs, and participate in FDA and other regulatory authority interactions on behalf of clients. The ideal candidate will possess project management skills and be adept at managing many competing priorities and projects. Must be results oriented, have a pragmatic approach to problem solving, and have interpersonal skills to act as an advocate for consensus on complex issues. This person must have in-depth knowledge of all aspects of clinical research and regulatory guidance.

Job Responsibilities
Act as subject matter expert at a governance-level for clients, as well as function as a liaison between Accenture and clients
Work closely with senior-level management
Assist Senior Leadership in defining and achieving departmental goals
Communicate departmental goals and achievements effectively
Provide inputs on department strategic needs: resources, technology, process improvements, and business opportunities
Support business development on proposal development and client meetings/presentations as requested
Review and approve all relevant client proposals, pricing, and scope changes
Verify and approve project time and expense charges
Understand methodology for all markets and service lines
Manage and build external networks to help sell projects and ideas and help to facilitate groups
Recognize new opportunities for additional business in projects and support the efforts of Accenture to acquire profitable client projects
Oversee project teams and serve as a subject matter expert for project teams
Responsible for the management of multiple projects
Communicate task level expectations to project teams
Track projects to the task level and prepare project progress reports
Lead the issue resolution process as needed
Ensure that project teams strictly adhere to internal standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the project lifecycle

Basic Qualifications
Bachelors degree
Minimum of 8 years of experience in the Pharma/Health industry with a strong emphasis in clinical data management, clinical programming and/or biometrics statistics
Minimum of 5 years of management experience
Preferred Qualifications
Masters degree
Experience in use of clinical data management or data conversion/warehousing systems and/or associated programming languages such as SAS, SQL, and Oracle.
Strong knowledge and experience with programming, SDTM, and ADAM in a clinical setting, as well as understanding of Clinical Statistics.
Knowledge of clinical trials conduct, plus the data and reporting requirements for clinical trials.
Experience in, and understanding of, a service provider environment.
Knowledge of regulatory submission process.
Experience with interactions (direct or indirect) with FDA and other regulatory authorities.
Competent in the use of MS Office applications.
Thorough knowledge of medical terminology.
Knowledge of GCP, ICH, and other applicable regulations.
Knowledge of quality assurance processes in a FDA and other regulatory authority regulated software development environment.
Self-directed and detailed-oriented.
Experience in leadership management
Professional Qualifications
Strong written, oral, and presentation communication skills
Ability to make professional and credible first impressions with external clients, maintain strong interpersonal skills with both internal and external clients and respond effectively to sensitive inquiries
Ability to engage the client and manage client expectations
Demonstrated record of leadership and organizational development
Proven business skills and operational management experience is essential
Outstanding project management and client management skills
Anticipate potential problems and recognize actual problems
Identify the strengths and weaknesses of alternative solutions to problems
Exercise judgment by considering relative costs and benefits of alternative courses of action

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


Posted: 2020-08-24 Expires: 2020-10-23

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Clinical Data Operations & Biometrics Lead

Philadelphia, PA 19133

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