Associate Lead Data Manager

Kelly Science, Engineering, Technology & Telecom; Colombia; Presencial; COP 90.000.000 - 150.000.000; Jornada completa

Descripción de la vacante

Kelly Science, Engineering, Technology & Telecom seeks an Associate Lead Data Manager to drive high-quality clinical data management across trials. You will collaborate with Lead Data Managers and global teams to ensure data accuracy, completeness, and readiness for analysis.

Responsibilities include developing data management plans, conducting data review, overseeing data cleaning and query resolution, supporting external data reconciliation, and mentoring junior staff to improve data quality

Formación

• Minimum degree or equivalent in life sciences or related field.
• Experience managing clinical data across pharmaceutical trials, start-up to database lock.
• Strong knowledge of data management principles, processes and docs.
• Experience with data review, cleaning, query management, and issue resolution.
• Proficiency with EDC systems and trial tech.
• Ability to review trial data, listings, and reports.
• Experience coordinating cross-functional and vendor activities.
• Familiarity with CDISC standards (CDASH/SDTM/ADaM).

Responsabilidades

• Support planning, coordination and delivery of data management activities across studies.
• Under supervision of Lead Data Manager, meet milestones and deliverables on time.
• Develop and review Data Management Plans and Data Validation Specifications.
• Coordinate data review, cleaning, queries, and issue resolution.
• Assist with external data reconciliation (lab, ECG, imaging, eCOA, ePRO, PK).
• Support design, testing and implementation of data capture systems.
• Participate in UAT, validation, and change control activities.
• Monitor data management metrics, risks and deliverables; escalate as needed.
• Mentor Clinical Data Coordinators and junior staff.
• Identify process improvements to enhance data quality and efficiency.

Conocimientos

Clinical data mgmt

Cross-functional collab

Data review

EDC systems

Vendor oversight

Regulatory compliance

CDISC standards

SQL/SAS/R

Mentoring

Educación

Life sciences or related

Herramientas

Medidata Rave

Oracle Clinical

REDCap

Other platforms

Descripción del empleo

This is a pipeline opportunity for proactive candidates interested in joining a global leader in the life sciences industry.

We are seeking an Associate Lead Data Manager to support the delivery of high-quality clinical data management activities across pharmaceutical clinical trials. In this role, you will work closely with Lead Data Managers, Clinical Operations, Biostatistics, Medical, Pharmacovigilance, Statistical Programming, and external vendors to ensure that clinical trial data is accurate, complete, consistent, and ready for analysis.

This is an excellent opportunity for a highly organised and collaborative professional who is looking to develop their leadership experience while contributing to the successful delivery of clinical studies.

What You’ll Do

• Support the planning, coordination, and delivery of clinical data management activities across assigned clinical studies.
• Work under the direction of the Lead Data Manager to ensure study milestones and data management deliverables are achieved on time.
• Contribute to the development and review of key study documents, including:
• Data Management Plans
• Data Review Plans
• Data Validation Specifications
• Case Report Forms and electronic Case Report Forms
• Data transfer specifications
• Coordinate data review, cleaning, query management, and issue resolution activities.
• Review clinical trial data for completeness, consistency, accuracy, and compliance with study requirements.
• Support the identification, documentation, and resolution of data discrepancies and trends.
• Assist with the oversight and reconciliation of external data sources, including laboratory, imaging, ECG, pharmacokinetic, eCOA, ePRO, and other vendor data.
• Support the design, testing, and implementation of clinical databases and electronic data capture systems.
• Participate in user acceptance testing, system validation, and change control activities.
• Monitor data management metrics, timelines, risks, and outstanding deliverables.
• Escalate significant data issues, study risks, or delivery concerns to the Lead Data Manager.
• Support interim database freezes, data cuts, and final database lock activities.
• Review data listings, reports, dashboards, and reconciliation outputs.
• Contribute to the development and maintenance of data management procedures, work instructions, and training materials.
• Support vendor oversight activities, including review of deliverables, issue management, and performance tracking.
• Participate in study team meetings and provide updates on data management progress and risks.
• Support inspection readiness, audit activities, and the preparation of relevant documentation.
• Mentor or provide guidance to Clinical Data Coordinators and less experienced team members.
• Identify opportunities to improve processes, data quality, efficiency, and consistency across studies.

What You’ll Bring

• Previous experience in clinical data management within a pharmaceutical, biotechnology, medical device, or contract research organisation.
• Experience supporting clinical trials from study start-up through database lock.
• Strong understanding of clinical data management principles, processes, and documentation.
• Experience with data review, data cleaning, query management, and issue resolution.
• Experience working with electronic data capture systems and clinical trial technologies.
• Ability to review and interpret clinical trial data, specifications, listings, and reports.
• Experience coordinating activities across cross-functional teams and external vendors.
• Strong understanding of data quality, data integrity, and controlled processes.
• Excellent organisational and time-management skills.
• Ability to manage competing priorities and work effectively to study timelines.
• Strong written and verbal communication skills.
• Ability to identify risks, investigate issues, and escalation appropriately.
• Proficiency in Microsoft Office, particularly Excel.
• Degree, diploma, or equivalent experience in life sciences, health sciences, pharmacy, nursing, biomedical science, clinical research, data management, or a related discipline.
• Experience supporting or leading clinical data management activities on global or complex clinical studies.
• Experience with clinical data management systems such as:
• Medidata Rave
• Oracle Clinical
• REDCap
• Other validated clinical data platforms
• Knowledge of CDISC standards, including CDASH, SDTM, and ADaM.
• Experience developing or reviewing data validation checks and edit check specifications.
• Experience with external data reconciliation, including laboratory, ECG, imaging, eCOA, ePRO, PK, or biomarker data.
• Experience supporting database lock, interim data cuts, or regulatory submissions.
• Experience with vendor management and oversight.
• Familiarity with clinical trial regulations and guidelines, including ICH-GCP.
• Experience with audit or regulatory inspection preparation.
• Knowledge of data visualisation, reporting, or analytics tools.
• Experience mentoring, coaching, or providing technical guidance to colleagues.
• Familiarity with programming or query languages such as SQL, SAS, or R.
• Experience working in a global, matrixed, or multi-study environment.