Praca Clinical Data Manager

Summary of Job Specification



Clinical Data Manager applies data management expertise and computer skills in support of the data management activities of drug and vaccine development programs. May be responsible for the following: managing central and local laboratory data; managing case report form (CRF. eCRF) clinical data; assessing data quality; and performing manual term encoding. In addition, provides documentation that details these work activities based on internal standard operating procedures without guidance from senior staff. Interacts effectively and works closely with people across functional areas within the organization as well as global customers and vendor partner. Clinical Data Manager may also assume people management responsibilities.



Detailed Job Duties and Responsibilities



Coordinates and performs the collection and processing of CRF data Performs data management activities, which may include any of the following: data receipt, data entry, and initial and final data review, and discrepancy resolution following Clinical Data Management SOP and ICH/GCP practices

Responsible for using manual and automated methods to perform clinical data review and medical review to ensure the overall integrity and consistency of the clinical trial data.

Interacts with investigation sites for data discrepancy resolution at global level.

Encodes unrecognized terminology entered into the database using MedDRA and other dictionaries, resolves encoding data discrepancies, and supports re-encoding of terminology due to vocabulary updates.

Coordinates the collection and processing of laboratory data.

Responsibilities may include: identifying and resolving central and local data quality issues, and maintaining standard central and local data management practices.

Maintains process performance metrics and reviews them periodically with department head to identify areas where efficiency can be improved.

Possibly supports user acceptance testing activities of Clinical Data Management tools

Communicates with customer and partner about project related issues or based on defined communication responsibilities in SOP

May participate in a continuous improvement special project related

Participate in outside normal business hours teleconferences as project requires

Coordinates and performs DM set-up process, CRF/eCRF set-up, collector design, edit definitions, report requirement definition, requirement documentation and testing

Provides active input in project planning as it relates to DM milestones

Provides execution guidance and mentoring support to Junior Clinical Data Associate/Clinical Data Associates



Portfolio level responsibilities



Responsible for accurate resourcing of assigned clinical trial portfolio

Ensures consistency in execution across assigned trial portfolio

Ensures selected vendors meet service level commitments

Possibly support procurement to estimates project costs from DM point of view



People Management and People Supervising Responsibilities



May manage, train and evaluate assigned personnel (Junior Clinical Data Associate and Clinical Data Associate)

May verifies adherence direct reports adherence of executions with SOP and ICH/GCP

May be responsible for ensuring proper execution and adherence to standard DM training and Mentoring plans



Education / Qualifications / Experience / Skills Requirements



B.S. degree in Medical, Pharmacy, Nursing, Biology or related discipline.

Good communication and interpersonal skills.

Strong application skills in computer systems

Detailed oriented

Excellent English, both written and verbal

Minimum of 5 years experiences in Clinical Data Management, Clinical Research or in a clinical or bio medical

Good knowledge of late stage clinical data management processes – Study set-up/Execution/Database lock

Experienced user of one or more EDC tools or Clinical Data Management System(s) for example Oracle Clinical or Clintrial, Rave, Inform

Excellent knowledge of ICH/GCP including, understanding of regulatory requirements and European Directive

Ability to work independently and efficiently

Work effectively in a team

Excellent coordination and project management skills



Travel



Available for traveling, including overnight stays as necessary