Ref #: 29638

Employment type: Permanent - Full-Time

Location: Taipei, Taiwan

Posted: 02-Jun-2021

Description

If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. We are hiring a Global Data Management to work closely with our client, a leading pharmaceutical company.


Overview
o Services rendered will adhere to applicable company 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).


Key responsibilities
o Services rendered will adhere to applicable company 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

Advanced:
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.


Required experience and qualifications
• 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


Why join the DOCS team at ICON?
Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.

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