Sr. Specialist, Clinical Data Management

rnational guidelines regarding data management of clinical trials is required. This position needs to understand relevant system/technical knowledge. In-depth knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) is required. Knowledge of technology platforms, confidentiality for data exchange, and project management and techniques is required.

• Supervision Received: Work is received in broad terms. Work is reviewed during major deliverables. Amount of instruction is limited. Work is reviewed with the Data Manager Leaders as well as with the immediate manager.

• Supervision Given: There are no direct reports for this position. This position collaborates with Vendors/CROs to achieve successful, cooperative partnerships. This position may delegate tasks and assignments to Global Data Managers. The Senior Specialist recognizes opportunities and contributes to solutions to strengthen the vendor/CRO relationship.

• GDO Common Competencies: Primarily at the Learning or Applying Level, see Appendix for competencies and proficiency levels.

• DM Specific Competencies: Primarily at the Learning or Applying Level, see Appendix for competencies and proficiency levels.

Principal Responsibilities:
• Takes a leadership role with the CRO, the trial customer(s) and other internal and external partnersto establish, align and confirm data management expectations for assigned trial(s).
• With the trial customer, CRO and other functional partners:
o Gathers content and integration requirements for eCRF and other data collection tools.
o Establishes conventions and quality expectations for clinical data.
o Establishes expectations for dataset content and structure.
o Set timelines and follow-up regularly to ensure delivery of all Data Management milestones.

• Performs trial level oversight controls as described in the oversight plan, QC process and workinstructions with minimal DML direction.
• Reviews clinical data management documents (including submission package) ensuring appropriatequality, scientific content, organization, clarity, accuracy, format and consistency. Ensurescompliance with regulatory guidelines and the documentation matrix.
• Ensures real-time inspection readiness of all DM deliverables for the trial; Participate in RegulatoryAgency and J&J internal audits as necessary.
• Plans and tracks content, format, quality, and timing of data management deliverables, including,but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, finaldatasets, submission plan and archival. Ensures deliverables are on time.
• Takes a leadership role with the assigned clinical working group(s) to ensure that DM and TA trialneeds and deliverables are met.
• Identifies and communicates lessons learned, best practices and frequently asked questions at thetrial level.
• Identifies and participates in process, system, and tool improvement initiatives within DM.
• Presents and trains at investigator and monitor meetings.
• May undertake the principal responsibilities of a CDM, as appropriate.

Qualifications

Education and Experience Requirements:

Core Experience:
• BS/BA degree or professional experience equivalent
• Data management experience
• Experience in clinical drug development within the pharmaceutical industry or related industry
Desired Experience:
• Vendor oversight experience
• Team leadership experience
• Project management experience
Potential Accelerator Opportunities:
• Build specific domain expertise (e.g., contracts, budget, etc.).
• Remain current with new and changing developments in data management and share withcolleagues.
• Remain current with the regulatory environment in clinical trials and proactively shareknowledge with colleagues.
• Drive consistency for an activity across a drug program (e.g., lab processing).
• Volunteer for a leadership role in a project or activity.
• Make presentations to senior level management for enhanced visibility.
• Take a leadership role in a process improvement initiative.
• Volunteer to mentor a Global Data Manager at the trial level.

It is important that you are effective in achieving your current goals and objectives, prior to engaging in accelerator experiences.