Senior clinical data associate(sitero)

12/15/20252 min read

Roles and Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES
You would be responsible for:
· 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.

all job listings