Clinical Data Manager

KPS Life; Malvern (Chester County); On-site; USD 95,000 - 125,000; Full time

Job summary

KPS Life is seeking a Clinical Data Manager (CDM) to oversee data management activities for Sponsor programs, coordinate with vendors, and ensure data capture, cleaning and secure database delivery.

The CDM will participate in clinical meetings, establish secure data sharing procedures, manage data management resources, and ensure compliance with EMEA, FDA, and ICH GCP guidelines and Sponsor SOPs. Strong leadership and mentoring skills are essential.

Qualifications

• Oversee data management for Sponsor studies and manage vendors and data feeds.
• Ensure data capture, cleaning and secure database delivery.
• Establish secure data sharing procedures with executives and stakeholders.
• Coordinate data management resources across clinical studies.
• Adhere to ICH GCP, FDA and EMA regulations and Sponsor SOPs.

Responsibilities

• participate in clinical meetings with Sponsor and KPS personnel as required.
• take necessary actions to ensure data management deliverables are met.
• establish rules and procedures for secure and responsible data sharing with executives.
• manage data management resourcing for all clinical studies, as required.
• prepare documents and ensure tools are arranged to allow for data capture and data cleaning.
• ensure delivery of an clean and secure database.
• instruct, communicate, coach and mentor others on data management procedures.
• ensure compliance with EMEA, FDA, and ICH GCP regulations and policies.
• ensure compliance with appropriate Sponsor SOPs.

Skills

Data management

Project management

Mentoring

EDC systems

Regulatory compliance

Communication skills

Education

BS/BA in biology/analytical/health data

Tools

Oracle Clinical

Medidata RAVE

Inform

Job description

• extensiveandcomprehensiveknowledgeofinternationalICHGCP guidelines.

The primary responsibility of the Clinical Data Manager (CDM) is to oversee and manage the Sponsor’s clinical programswithregardstodatamanagementactivitiesforSponsor/designee. This includes management, if required, of any 3rd party vendors and data feeds from those 3rd party suppliers of the Sponsor.

The CDM will:

• participate in clinical meetings with Sponsor and KPS personnel as required.
• take necessary actions to ensure data management deliverables are met.
• establish rules and procedures for secure and responsible data sharing with executives.
• manage data management resourcing for all clinical studies, as required.
• prepare documents and ensure tools are arranged to allow for data capture and data cleaning.
• ensure delivery of an clean and secure database.
• instruct, communicate, coach and mentor others on data management procedures.
• ensure compliance with EMEA, FDA, and ICH GCP regulations and policies.
• ensure compliance with appropriate Sponsor SOPs.

The CDM will have:

• BS/BA degree with preference in a biological, analytical/data, health-related, or computer science field.
• 7-10 years related experience in a pharmaceutical or CRO setting.
• 5 years’ experience in Data Management.
• A knowledge of EDC solutions (Oracle Clinical, Medidata RAVE, Inform, etc.).
• Experience working on studies both in source and outsourced to a CRO.
  • Current computer literacy in appropriate software (i.e. Current with recent versions of Microsoft Office software suite).
• Strong management and motivation skills.
• The ability to manage study teams and perform issue escalation to meet database cleaning and lock timelines.
  • Extensive and comprehensive knowledge of international ICH GCP guidelines.

excellentinterpersonal,writtenandoralcommunication skills.