PB0082 - Sr. Clinical Data Manager (#212036)

PB0082 - Sr. Clinical Data Manager (#212036)

92. PB0082 - Sr. Clinical Data Manager (#212036) Posted:


Database Programmer
Irvine, CA USA Perm Placement
$93,000 Starts:
Ends:



Description:
The Senior 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.
Acting as a Lead Data Manager for less complex studies, and as determined by ability and proficiency level in essentials skills.

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 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:

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.

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.

Clinical Study Team Member
Assist with the role which includes representation of the clinical data management & programming organization in one or more clinical study team.

Subject Matter Expert
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.





Requirements:
- Degree or equivalent experience in Clinical Research, Computer Science, Project Management or related field: 6 years experience, or BS/BA degree with 4 years experience, or MS degree with 2 years experience.
- Minimum 2 years experience within a clinical data management organization, preferably within medium-large pharma or CRO.
- 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
- Ability to travel 5%.

For immediate consideration, please send your resume to or call: .

Skills:

Travel Amount:



Benefits:

Relocation Covered: