Description
The Manager within Clinical Data Management will direct internal and/or outsourced data management activities in support of multiple clinical research projects. The position is responsible for-Supervision of clinical data management professionals (internal and/or outsourced) working within clinical study teams as a direct or extended team member.
Manages the operations of a team to maintain focus on quality clinical data management deliverables against defined project timelines and priorities.
Contributing to the definition of global clinical data management procedures compliant with regulatory and internal requirements.
Using metrics to ensure effective and efficient clinical data management contribution to the clinical study team.
Collaboration with peers within and outside the GDO organization to pro-actively maintain effective contribution from clinical data management to the clinical study teams.
May be required to act as Lead Data Manager for one or more studies.
The employee is expected to be Skilled 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.
The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Company policies, and procedures. Company policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
KEY DUTIES AND RESPONSIBILITIES:
Data Management Team Leader
Responsible for the role which includes alignment of data management & programming staff with corporate project goals and milestones. Promotion of project management excellence in support of the clinical study teams. Management review and approval of clinical data management study documentation (e.g. Data Management Plan, Edit Check Specifications, etc.).
Lead Data Manager
Responsible for the role which includes executing the design, documentation, testing, and implementation of data collection systems and processes in support of the clinical study teams. Training of study site personnel in CRF completion, and data clarification processes.
Coordination of all Data Management Data Review activities and any other Clinical Study Team Data Review (e.g. Masked Data Review). Ensuring completion of all activities leading to the Study Database Lock.
Study Data Manager
Responsible for 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.
Qualifications Education and Experience:
- * Degree or equivalent experience in Clinical Research, Computer Science, Project Management or related field: 11 years experience, or BS/BA degree with 9 years experience, or MS degree with 7 years experience, or PhD degree with 4 years experience.
- * Minimum 4 years experience in a leadership role within a clinical data management organization, preferably within medium-large pharma or CRO.
- * Ability to travel 5-10%
- * Advanced knowledge and understanding of regulatory guidelines for the use of computer systems in clinical trials
- * Advanced knowledge of Research & Development and an understanding of regulatory guidelines/requirements related to R&D (e.g., ICH, GCP, safety reporting)
- * Advanced knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.).
Competencies/Skills
- * Demonstrated ability to influence others without direct reporting relationships
- * Ability to multi-task and prioritize
- * Document writing skills
- * Attention to detail with high quality outputs
- * Proactive and critical evaluation of varied and multiple aspects of trial
implementation to ensure timely completion and with requisite quality
- * Computer skills (word processing, spreadsheets, graphics, PowerPoint)
To find out more about Real please visit www.realstaffing.com