Clinical Data Acquisition Manager
An attractive job opportunity has arisen at a leading multinational pharmaceutical company who is seeking a Clinical Data Acquisition Manager to work at their Amsterdam site. The company employs 100,000 personnel across 150 countries, working across multiple therapy areas including cardiovascular, oncology, and respiratory.
- Acting 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).
- Ensuring data collection applications are consistent and comply with company and industry standards with respect to quality and timelines.
- 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).
- Leading 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.
- Acting 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 and matters.
- Leading the implementation or improvement of DM processes, trainings, systems/tools,
vendor quality assessments, audits and inspections - related to data collection and
management applications - in providing technical expertise.
- Acting 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.
- Ensuring the study eDC/ePRO is delivered with quality and on time, when the Data management activities are conducted internally.
- Providing input to study design, the clinical protocol, study planning and review of study
documents as appropriate.
- Ensuring quality control and quality audit of deliverables.
- Understanding, mediating and solving issues related to eDC/ePRO study set-up deliverables and escalated as appropriate to the Study Data Manager and/or the Oversight Data Manager.
Skills and Requirements:
- 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.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Emma Adams at +44 203 854 3893 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.