Senior Specialist - Clinical Data Acquisition Manager

Site Name: Netherlands - Amsterdam
Posted Date: Feb 12 2020
Job Purpose: As the Senior Clinical Data Acquisition Manager, you act as a Subject Matter Expert leading and/or being responsible for the end-to-end study set-up and the technical development of Electronic Data capture (eDC) and/or Electronic Patient Reported Outcomes (ePRO) solutions for preclinical, clinical and epidemiological data management activities for their assigned study(ies).
You ensure data collection applications are consistent and comply with company and industry standards with respect to quality and timelines.

Key Responsibility:

  • You have the accountability for one or several complex studies, and performs the full set of activities of the Data Acquisition Manager and have the ability and the seniority to manage the delivery of any type of studies (different areas, complex/unusual early setting, new/unusual indication, pivotal / Phase III and efficacy studies, clinical as well as epidemiology)
  • You lead and are responsible for the study set-up and the technical development of Electronic Data capture (eDC) and/or Electronic Patient Reported Outcomes (ePRO) solutions for preclinical, clinical and epidemiological end-to-end data management activities for a study or a group of studies by developing data collection and management applications in-house
  • You act as the key point of contact or/and as an advisor for key stakeholders (Clinical and Epidemiological Core Teams (CECT) and the Study Core Teams (SCT) members) in providing DM operational/requirements specification input about the eDC/ePRO study set-up related activities & matters
  • You lead the implementation or improvement of DM processes, trainings, systems/tools, vendor quality assessments, audits and inspections - related to data collection & management applications - in providing technical expertise
  • You act as mentor in your expertise area to shorten the learning curve of the more junior profiles and act as a reference model within the Data Acquisition team
  • When the Data management activities are conducted internally, you ensure the study eDC/ePRO is delivered with quality and on time
  • You provides input to study design, the clinical protocol, study planning and review of study documents as appropriate
  • You ensure quality control and quality audit of deliverables
  • You understands, mediate and solve issues related to eDC/ePRO study set-up deliverables and escalated as appropriate to the Study Data Manager and/or the Oversight Data Manager
*LI-GSK

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
  • Masters or equivalent in Engineering, Life Sciences, Computer Sciences, Mathematics and/or Physics
  • Minimum 7 years in similar or related job experience in Clinical Research or Information Systems and/or relevant scientific experience
  • Experienced in Data Management in the pharmaceutical industry,
  • Experienced in eDC & ePRO solutions and others clinical systems & database (SQLs included)
  • Experience of managing business remotely in a matrix network
  • CDISC Knowledge
  • Understanding of general data flow & database architecture concepts
  • Good understanding of regulations including ICH-GCP
  • Strong knowledge / experienced in IT tools and validation methodology
  • Fluent English (written and spoken)
  • Willing to work in an international environment
  • Innovative/Flexible thinking, process minded, keeping openness for specific project needs
  • Strong ability to mentor teams


Preferred Qualifications:
If you have the following characteristics, it would be a plus:
  • Good communication skills within a matrix environment
  • Presentation & training skills
  • Team spirit - ability to facilitate interfaces within extended network
  • Good time management skills: ability to manage time and priorities
  • Good analytical, problem solving and project delivery skills
  • SAS basics or statistical software is an asset
  • Ability to anticipate for changes and be flexible in their implementation
  • Problem solving mindset
  • Quick learner
  • Ability to handle technical and complex topics
  • Proactive, flexible and stress resistant
  • Results oriented and customer focused
  • Capable to manage planning conflicts with a high level of complexity during multi-disciplinary meetings when participants have different concerns and to propose pragmatic solutions

Why GSK?
Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

GSK Vaccines- Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.
For further information, please visit www.gsk.com .

Our Department:
Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation's three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

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