External Data Acquisition Manager, Open to flexible working
1 day left
- Contract Type
Global Clinical Operations is transforming to fulfil our vision to "Be the best performing and trusted Global Clinical Operations organization". Our mission is to "Accelerate the pipeline through innovative, efficient and expeditious delivery of high-quality data"
As the External Data Acquisition Manager you will be primarily responsible for the technical & vendor oversight of ePRO, eCOA and other external vendor data solutions ( eg central labs, biomarkers, scans etc) for clinical and epidemiological studies managed internally.
In this role you will ensure ePRO, eCOA, external vendor data solutions are consistent and comply with company and industry standards with respect to quality and timelines.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Is responsible for the technical & vendor oversight of ePRO & eCOA solutions and other external vendor data (e.g. biomarker, genomic data) for one or more clinical & epidemiology study(ies) managed internally
For the studies you are in charge of:
- Acts as a key point of contact or/and an advisor for key stakeholders and the Study Core Teams (SCT) members - including the Study Data Manager - for ePRO & eCOA and other external vendor data study related activities & matters
- Coordinates review, revision, and approval of study specification documents (including operational requirements & specifications) and key vendor deliverables (including translations)
- Provides input to study design, the clinical protocol, study planning and review of study documents as appropriate
- Ensures quality control and quality audit of deliverables
- Oversees vendor Supply management of ePRO & eCOA materials
- Ensures quality control of deliverables
- Understands, mediates and solves issues related to ePRO, eCOA , other external vendor data and escalate as appropriate to the Study Data Manager
When studies are outsourced either through an e2e DM FSP model or through FSO, supports the Study Data Manager & Oversight Data Manager in specific ePRO, eCOA, and other external vendor data matters or issues.
As an Subject Matter Expert, contributes to the implementation of new ePRO, eCOA, and other external vendor data processes, associated written standards, trainings, vendor selection & quality assessments, audits and inspections
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent
- 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 ePRO & eCOA and other external vendor data solutions (at Vendor or Sponsor side)
If you have the following characteristics, it would be a plus:
- Post Graduate degree in Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent
- Experience of managing business remotely in a matrix network
- Understanding of general data flow & database architecture concepts
- Good understanding of regulations including ICH-GCP
- Strong knowledge / experienced in IT tools and validation methodology
Our values and expectations are 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. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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