Senior Clinical Data Associate

Senior Clinical Data Associate
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have
experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled
solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III
clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all
stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
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.