Ref #: 27980

Employment type: Permanent - Full-Time

Location: Buenos Aires

Posted: 08-Apr-2021

Description

JOB FUNCITIONS

Base:
Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local
regulatory requirements, etc.
o Provides data management support, oversight and/or accountability for one or more clinical
trials.
o May Take a leadership role with the CRO, the trial customer(s) and other internal and external
partners to establish, align and confirm data management expectations for assigned trial(s).
o With the trial customer, CRO and other functional partners: – Gathers content and integration
requirements for eCRF and other data collection tools. – Establishes conventions and quality
expectations for clinical data. – Establishes expectations for dataset content and structure. – Set
timelines and follow-up regularly to ensure delivery of all Data Management milestones.
o Performs trial level oversight controls as described in the oversight plan, QC process and work
instructions with minimal DML direction.
o Reviews clinical data management documents (including submission package) ensuring
appropriate quality, scientific content, organization, clarity, accuracy, format and consistency.
Ensures compliance with regulatory guidelines and the documentation matrix.
o Ensures real-time inspection readiness of all Data Management deliverables for the trial;
Participate in Regulatory Agency and J&J internal audits as necessary.
o Helps plan and track content, format, quality, and timing of data management deliverables,
including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release
plan, final datasets, submission plan and archival. Ensures deliverables are on time.
o Participates in the assigned clinical working group(s) to ensure that Data Management and TA
trial needs and deliverables are met.
o Helps Identify and communicate lessons learned, best practices and frequently asked questions
the trial level.
o Presents and trains at investigator and monitor meetings if needed

Senior:
o Takes a leadership role in planning and tracking content, format, quality, and timing of data
management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight
plan, database release plan, final datasets, submission plan and archival. Ensures deliverables
are on time.
o Takes a leadership role with the assigned clinical working group(s) to ensure that Data
Management and TA trial needs and deliverables are met.
o Takes a leadership role in Identifying and communicating lessons learned, best practices and
frequently asked questions at the trial level.
Metrics/KPIs: Metrics/KPIs governing these services are outlined in the QOP document.

EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS
• Data Management experience preferred / required for based and advanced level
• Experience working on a clinical trial.
• Experience working in highly diverse teams within clinical research; cross-functional, global,
multiregional.
• Project management skills.
• Vendor management skills.
• Advanced Microsoft Office skills including the ability to manipulate and analyze data.
• Highly organized with excellent written and verbal communication.
• Ability to interpret clinical trial data and present trends to clinical trial team on data.
GDM (grad) – graduate level: college graduates. <1 y experience
GDM – base level: 1-3 years of experience.
Sr. GDM – advanced level: +3 years of experience
• Bachelor’s degree or equivalent, in Health or Science discipline with experience in clinical research.

MUST have English as this is a Global role.

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