Senior Clinical Data Associate

Fresher
2 months ago 8 Applied
Job Description

  • Participating in the preparation/review of Data Management process control documents, including but not limited to the Data Management Plan, Data Validation Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, External Reconciliation plans, SAE Reconciliation, CRF Completion Guidelines, etc
  • May serve as the Lead Data Manager (client-facing role) on assigned projects.
  • Attending regular meetings with the Sponsor and project team for discussions relating to data management issues and providing status updates for the project with guidance from the Project Data Manager/Project Manager.
  • Effectively managing all data management aspects of assigned project(s) from set up to database lock.
  • Participating in in-house and external training courses, as required.
  • Demonstrating strong project management skills, client management skills, and a focus on customer needs.
  • Acting as a liaison to the leadership and client on all Data Management activities for the study.
  • Supervising the Data Management team.
  • Having knowledge of Medidata Rave or any other EDC tool, and exposure to Business Object/JReview experience, which is an added advantage.
  • Having the ability to set and meet timelines or recognize and schedule changes in response to project demands.
  • Having the ability to train, mentor, and direct the study team and perform ongoing quality control and data review.
  • Possessing knowledge of Clinical Protocol, data management plan, edit checks requirements, and data standards management.
  • Having TA-specific knowledge, SOP management, creation, and accountability of the process.
  • Producing project-specific status reports for management, PM, and/or clients on a regular basis and monitoring study metrics.
  • Coordinating and managing training and EDC access for investigators, coordinators, data entry, and CRAs on selected applications for data entry, cleaning, and running reports, as applicable to study parameters.
  • Demonstrating strong verbal and written communication skills.
  • Participating in eTMF audits as necessary and responding to auditors comments in a timely fashion.
  • Coordinating with the Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required.
  • Having a solid understanding and implementation of CDISC standards.
  • Demonstrating initiative and motivation.
  • Being capable of directing and promoting teamwork in a multi-disciplinary team setting.
  • Possessing excellent written and verbal communication skills.
  • Having a strong knowledge of ICH guidelines.

EDUCATION AND EXPERIENCE REQUIRED

  • Minimum Educational Requirement: Preferably a life science graduate or equivalent qualification.
  • 8-10 years of clinical data management experience within Contract Research Organizations (CRO), Pharmaceutical, or biotech industries.
  • Effective working knowledge of Microsoft Office Suite, including Word and Excel.
  • Demonstrated proactiveness, problem-solving, analytical, organizational, and time management skills.
  • Demonstrated flexibility and ability to work well in a fast-paced, growing organization.
  • Demonstrated ability to work in a global team environment.
  • Demonstrates a basic understanding of Clinical Trials and the flow of data.
  • Demonstrated ability to comply with ICH-GCP/ regional regulatory guidelines and POI SOPs.
  • Comprehension of study documentation standards including Trial Master File organization and archival processes.
  • Familiarization of data standards, preferably CDISC STDM.
  • Cross functional collaboration Stakeholder management
  • Coach/mentor new team members to support efficient and quick on-boarding.

COMPENSATION BENEFITS

  • Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

COMMITMENTS

  • Standard Hours 40 hours per week, one hour lunch, Monday - Friday. Additional hours as needed.
  • Willing to work in shifts as and when needed.

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