Sr Clinical Data Coordinator

Skills

Position Title: Senior Clinical Data Coordinator

Function/Department: Development Operations, Data Management

Reports to: Manager, Data Management

FLSA Category (US ONLY): Exempt

Job Description

Position Summary:

The Senior Clinical Data Coordinator (Sr. CDC) is a key member of the Clinical Development Operations, Data Management Team. The Senior Clinical Data Coordinator will provide data management support for all assigned studies. The Sr. CDC prepares, validates, processes, and maintains Clinical Data in support of submissions to international regulatory agencies or publication of manuscripts through the use of EDC and SAS software.

Position Responsibilities/

Accountabilities:

• Assist in the development of edit specifications, based on any available global medical standards, therapeutic area standards, and the protocol, used to clean the study.
• Performs user acceptance testing (UAT) on eCRF build and edit specifications.
• Creates supporting DM process documentation to LDM and/or performs peer review of documentation, including updating documentation.
• Support the coding schedule defined in the data management plan. Collaborate with data coding specialists on a regular basis to guarantee timely coding.
• Supports/maintains quarterly coding review cycles.
• Performs manual data listing reviews and submits queries as appropriate.
• Assist with and/or performs user acceptance testing of lab data standards.
• Evaluates quality of lab data entry and addresses inconsistencies with sites and CRAs as applicable.
• Assists in the SAE reconciliation process. This may include coordination with medical experts and Global Drug Safety. Follow up on discrepancies and resolve so both databases are consistent.
• Applies criteria for subject stage gate of No More Issues (NMI). Also, must coordinate and review medical and statistical queries and certify they are adequately resolved.
• Assist in the development of a blind review report and conducting a blind review meeting to assign patient validity..
• Assist in developing and generating study report listings according to ICH and if present company guidelines.
• Coordinate the query management system functions.
• Perform the final patient review and database lock activities.
• Assist in coordinating the processing of scheduled data transfers (PK/PD data, imaging data, Laboratory data) from external vendors and performs relevant review/reconciliation.
• Review query responses and ensure data quality.
• Reviews Site responses to queries and evaluates the necessity of a re-query. If applicable, communications with Site Coordinators are performed for resolution.
• Attends and may lead internal and external team meetings.
• Reviews and/or provides meeting minutes.
• Supports training and development of Clinical Data Coordinators.
• Assists with eCRF design. May be required to develop the eCRF and/or provide peer review.
• May serve as a back up to the LDM for internal and external study teams

Managerial Requirements/ Responsibilities:

N/A

Position Qualification Requirements:

Education: Bachelor’s degree in related discipline and three years of related experience; or high school diploma and four years of related experience.

Experience: See “Education.”

Required Certifications: May require certification in assigned area[FJ1] [MD2] .

NA

Required Skills:

• Proficient with Microsoft Office Suite.

• Excellent written and oral communication skills.
• Strong organizational, problem-solving, and analytical skills.
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities.
• Proven ability to handle multiple projects and meet deadlines.
• Strong interpersonal skills.
• Ability to deal effectively with a diversity of individuals at all organizational levels.
• Commitment to excellence and high standards.
• Creative, flexible, and innovative team player.
• Ability to work independently and as a member of various teams and committees.
• Good judgement with the ability to make timely and sound decisions.
• Ability to be discrete with sensitive company information.

Physical Demands (US ONLY):

Sedentary work that primarily involves sitting/standing

Acknowledgement:

My signature below acknowledges that I have read the above job description and agree that I can perform the responsibilities and meet the requirements as presented. I understand this job description provides a general outline of job responsibilities and requirements and is not intended to be all-inclusive. I also understand that job responsibilities and requirements may change at any given time based on organizational or departmental needs.

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