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Manager, Clinical Programming - Data Capture and Reporting

Allergan, Inc.

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Location: Bridgewater, NJ Posted Date: 4/24/2013 Position Type: Full time Job Code: 130721 Required Education: High school or equivalent

Description

About Allergan:
Founded in 1950, Allergan, Inc. (NYSE: AGN) is a global multi-specialty health care company headquartered in Southern California with rapidly growing annual revenues of $5+ billion.  The company’s two primary segments are specialty pharmaceuticals and medical devices. Allergan's flagship franchises in eye care, neurosciences, medical dermatology and urologics, structured under Allergan Pharmaceuticals, offer specialty physicians and their patients a wide range of treatments to help preserve and protect sight, reduce physical disability and enhance quality of life.  In 2006, Allergan added aesthetics and dermal fillers to its business portfolio to create a world-leading medical aesthetics franchise. At the same time, Allergan added a leading product portfolio in obesity intervention that offers minimally invasive devices to help patients achieve sustained weight loss and reduce health risks associated with obesity.    
About the Position:
The Manager, Clinical Programming leads internal and outsourced Clinical Programming Data Capture & Reporting personnel in support of activities for Clinical Research and Development studies.  Manage the design, development, validation, implementation and ongoing support for electronic systems (e.g. Electronic Data Capture) and reporting/business intelligence tools (e.g., Business Objects, Spotfire). Provides strategic input into the analysis of Clinical Study design requirements against third party system specifications to support the implementation of clinical systems. Supports the validation of electronic systems and programs as implemented internally or through external vendors according to current regulatory requirements. Lead the implementation of programming standards and conventions. The position is responsible for:
Management and oversight of the Data Capture & Reporting Clinical Programming team and external vendors.
Management and execution of clinical programming operations against project timelines, and any other priorities.
Identification and implementation management of defined department metrics as a framework for timely and quality of clinical programming deliverables.
Collaboration with management within and outside the Global Development Operations (GDO) organization.
The employee is expected to be skilled in performing all the roles encompassed in the preceding grade levels within the job family as required by the organization.  Other activities, special projects and assignments may be given as required.  As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.

The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Allergan policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Principal Responsibilities:

Line Function Manager
Responsible for the role which includes planning, organization, and management of all internal and external programming activities supporting clinical trials. Hire, train and manage performance of staff inclusive of orientation, training, personal development, completing and administering performance evaluations).  Works closely with human resources and temporary staffing agency (e.g., ADECCO) to ensure timely hiring of qualified resources.

Standards Management
Responsible for the role which includes support to the maintenance of Global Libraries and ensuring their synchronization with department standards (e.g. Standard Data Elements).  

Line Function Lead
Responsible for the role which includes developing procedures and documentation in support of the definition of, and project planning and requirements for study-specific program and software development.

AGN Personnel / Subject Matter Expert
Responsible for the role which includes participation in the identification, evaluation, recommendation, implementation and management of Clinical Information technology solutions to support Clinical study database activities including all forms of electronic data capture through in-house or third party vendors. Contribute to standardization of data capture, processing and reporting through traditional and innovative electronic solutions. Support Corrective Action and Preventive Action initiatives. Report process gaps and potential misconduct during clinical studies to management.

Clinical Programmer
Responsible for the role which includes document creation, development, peer review, validation, and maintenance of database systems and tools to support clinical research activities. Provide leadership and content expertise for programming activities from startup through the statistical analysis stage of clinical studies in support of Global Development Operations to effectively manage data capture, review and database lock activities.

Vendor Selection and Management Team Member
Responsible for the role which includes participating in the vendor selection process and managing the vendor in accordance with the approved Vendor Management Oversight Plan. Assessment/Re-assessment of Vendor capabilities, as necessary.

Requirements

Preferred candidates will have:
Degree in Computer Science, Life Science or related field: BS/BA degree with 9 years experience, or MS degree with 7 years experience, or PhD degree with 4 years experience.
Minimum 2 years experience in a leadership role within a clinical programming organization, preferably within medium-large Pharma or CRO.  
Technical abilities and skills in the analysis, design, specification and programming of computer systems using tools such as Electronic Data Capture and reporting/business intelligence tools (e.g., Business Objects, Spotfire)
Knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies
Knowledge of clinical Data Management and Clinical Programming methodologies as well as current and emerging global industry standards.
Working knowledge of global standards related to clinical study data management activities (CRF design, data standards (CDISC; SDTM, ODM), database design, coding and coding dictionaries, etc.).
Ability to effectively interact with and influence others without direct reporting relationships
Technical writing skills and experience
Analytical, problem solving and technical skills
Planning, organizational, and project management skills
Negotiation skills
Conflict management skills
Attention to detail with high quality outputs
Computer skills (MS Office; word processing, spreadsheets, graphics, PowerPoint)
Competencies and skills in the following: cross functional relationships, communication, execution/results/process improvement, customer satisfaction, people and talent management, strategic decision making, facilitating change, organization and industry awareness, influencing and team leadership, results orientation, ability to meet challenging milestones, ability to problem solve independently and with others
Ability to travel 15%
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