Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential. In making this commitment, we work to develop an unparalleled level of insight into patients' wants and needs — and into the priorities and concerns of the medical specialists who treat them. To this end, we employ more than 50 percent of our work force in either research and development (R&D) or sales, ensuring our efforts are focused on innovation and our customers.
Post: Clinical Data Manager
Job Description
The CDM (Clinical Data Manager) within Clinical Data Management will provide specialized knowledge and detailed attention to carry out data management data review activities in support of one or more clinical research studies. The position is responsible for:
- Working within clinical study teams as an extended team member,
- Executing the clinical data management operations against project timelines, and any other priorities,
- Using defined department metrics as a framework for timely and quality clinical data management deliverables,
- Collaborating with peers within and outside the GDO organization to pro-actively manage data availability and integration.
The employee is expected to be fully capable of 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.
Principal Responsibilities:
Study Data Manager
Assist with the role which includes the execution of the data review strategy for one or more studies as defined by the individual study Data Management Plan. Initiation and management of the data clarification process, coordinating with other stakeholders to ensure appropriate resolution to all data clarifications prior to database lock.
Study Data Associate
Assist with the role which includes development of clinical data management study documentation (e.g. Data Management Plan, Edit Check Specifications, etc.), and supporting the review in accordance with existing standards. Leadership of user acceptance testing activities of technologies implemented at a study level.
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AGN personnel / Subject Matter Expert
Responsible for the role which include implementation of quality, efficient, and consistent approaches to carrying out clinical data management tasks. Delivering training to clinical data management and other departments, as necessary. Report process gaps and potential misconduct during clinical studies to management. Support Corrective Action and Preventive Action initiatives.
Candidate Profile
- Preferred candidates will have:
- Degree in Clinical Research, Computer Science, Project Management or related field: 4 years experience, or BS/BA degree with 2 years experience, or MS degree.
- Knowledge and understanding of regulatory guidelines for the use of computer systems in clinical trials
- Knowledge of Research & Development and an understanding of regulatory guidelines/ requirements related to R & D (e.g., ICH, GCP, safety reporting)
- Working knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.)
- Competencies and skills in the following: Cross Functional Relationships, Communication, Decision Making, Execution/ Results/ Process Improvement, Customer Satisfaction
- Ability to effectively interact with and influence others without direct reporting relationships
- Ability to multi-task and prioritize
- Planning, organizational, and project management skills
- Document writing skills
- Attention to detail with high quality outputs
- Negotiation skills
- Conflict management skills
- Proactive and critical evaluation of varied and multiple aspects of trial implementation to ensure timely completion and with requisite quality
- Ability to meet challenging milestones
- Analytical and problem solving skills
- Computer skills (word processing, spreadsheets, graphics, PowerPoint)
- Ability to travel 5%
Additional Information
Experience: 2-4 year
Location: USA-CA-Irvine
Job Number: 131750
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
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