Principal Clinical Data Lead
- Employer
- ICON Strategic Solutions
- Location
- Ireland, United Kingdom
- Salary
- Competitive
- Start date
- 13 Nov 2022
- Closing date
- 13 Dec 2022
View more
- Discipline
- Data Management / Statistics, Clinical Data Management
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
- The Outsourced Data Management Operations Lead manages the end to end clinical data flow (data
acquisition from Case Report Form (CRF) development to Clinical Study Reporting (CSR) of Clinical
Data) and ensures timely project execution, quality data deliverables, and prioritization of all DM
milestone delivery. Recognized as the DM operational specialist in clinical data flow and study
execution by all functions within their assigned SMTs. - Is managed and directed by ICON Line Managers and supports ICON initiated internal process
improvement initiatives. The Outsourced Data Management Operations Lead will not be assigned to
support sponsor internal process improvement initiatives and will not attend sponsor company internal
events and/or town hall meetings. - By acting as the primary Data Management (DM) representative to the study management team, the
Outsourced DM Operations Lead partners with Sponsor Data Management Portfolio Lead and other
key study/program team members to implement project plans for assigned studies, ensuring the
functional activities are completed by external data vendors according to specified quality standards
and timelines, and for coordinating ongoing data management activities with external data vendors to
support the flawless execution of a clinical trial. - Uses phase, TA and operational knowledge to establish and implement study level operational plans
and oversees vendors to ensure on time project delivery on all assigned projects. - Develops study level quality/oversight plans and ensures adherence and consistent execution across the
data flow. Collaborates with sponsor DM Portfolio Leads to ensure alignment of study operational plans
with program goals. Contributes to and/or accountable to update and manage study dashboards,
timelines, resource prioritization, and data deliverables.
5 + years Relevant Clinical Data Management experience.
Highly computer literate, including strong Microsoft Office skills (Excel, Word, PowerPoint, Project)
Knowledge of clinical trial database technologies and processes.
Is accountable and proactive in quality and risk management.
Ability to liaise successfully with sponsors.
Excellent written and oral communication skills.
Excellent accuracy and attentiveness to detail.
Capability to work within a team environment.
Capability to manage competing priorities in a changeable environment.
Capability to handle stressful situations and deadlines.
Excellent interpersonal skills.
Previous experience and proven competence in managing study delivery through full DM lifecycle
(planning, start-up, conduct, lock and closeout)
Deep understanding of drug development and biopharmaceutical industry required
Robust experience with Medidata Rave and use of Data Review tools such as J-Review or Business
Objects required
Strong project management skills, and ability to effectively lead and collaborate with various business
functions project management certified desirable
High attention to detail including proven ability to manage multiple, competing priorities
Experience working on outsourced clinical trials
Experience developing and implementing DM process and data standards
Demonstrated ability to establish effective business process and relationships with external
stakeholders, including implementing process change
Demonstrated ability to influence without authority
Company
As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond.
ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world’s leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact.
Why choose a career with ICON Strategic Solutions?
Meaningful Work: You’ll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives.
Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally.
Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently.
Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization.
Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.
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