Lead Data Manager
- United States
- Clinical Data Management, Clinical Data Scientist Lead, Clinical Systems, Data Standards Consultant
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
As a Lead Data Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
The Lead Data Manager (LDM) is capable of leading Data Management aspects of a clinical study with some support and oversight and will ensure that study level deliverables are completed on time, with quality, and in accordance with corporate and regulatory requirements. The LDM has a working knowledge of FDA regulations and general industry standards.
- Lead all data management aspects of a clinical study with minimal oversight, including study start-up activities, and guide the study team through change orders and protocol amendments
- With minimal oversight, develop DM documents including, but not limited to, Data Management Plans, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans. Utilize templates and standard guidelines to initiate documents, but exercise critical thinking and discretion to tailor documents to study needs
- With minimal oversight, lead data cleaning activities such as, but not limited to, study team data reviews, Non-system Edit Check Output review, SAE reconciliation and non-CRF data reconciliation. Gather cross-functional input to create custom data review plans. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths
- Demonstrate collaboration and relationship-building with all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics scientists, Medical Writers, Regulatory representatives, etc.)
- Run SAS programs, review SAS logs, and generate output. Research and resolve even complex data discrepancies. May program SAS Non System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill level
- With minimal oversight, manage data deliverables processes, including database locks
- DM Project Management: With oversight, ensure data management deliverables are met on time. Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities. Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables. Provide solutions for data management issues that arise during study conduct
- Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product
- Demonstrate "everyday leader" qualities
You are:
- Years of experience: 3-7 years; dependent on level of related skills and education
- Effective organizational and communication skills
- Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession
- Detail oriented; performs quality and accurate work
- Thorough knowledge of FDA regulations and ICH GCP guidelines and the DM Lifecycle; subject matter expertise may substitute for broader DM lifecycle knowledge
- Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively
- Preferred:
- Previous experience with RTSM/IWRS and ePRO systems
- Database development experience
- SAS programming experience
- Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials
- Previous relevant EDC experience
- Previous vendor/CRO management
- Oncology experience and/or working knowledge
- BA/BS in relevant field. Years of experience may substitute for education.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Career ProgressionContent type
BlogsPublish date
05/10/2024
Summary
Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv
Teaser label
Our PeopleContent type
BlogsPublish date
10/02/2023
Summary
An Evolution of Progress and Success: Zashan's story a Clinical Research Associate (CRA) Having a satisfying career involves finding a company that prioritizes progress, improvement, and chances f
Teaser label
Our PeopleContent type
BlogsPublish date
08/22/2023
Summary
Skip to SAS Programming jobs What is SAS Programming? A statistical software suite called SAS for data management was established by the SAS Institute between 1966 and 1976 for the purposes
Similar jobs at ICON
Salary
Location
United Kingdom
Department
Biometrics Roles
Location
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-113703
Expiry date
01/01/0001
Author
Matt BarkerAuthor
Matt BarkerSalary
Location
United States
Department
Biometrics Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
As a Lead Data Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-113459
Expiry date
01/01/0001
Author
Jeffrey VillasenorAuthor
Jeffrey VillasenorSalary
Location
United Kingdom, Spain, Poland
Department
Biometrics Roles
Location
Poland
Spain
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
2024-113230
Expiry date
01/01/0001
Author
Matt BarkerAuthor
Matt BarkerSalary
Location
United States
Department
Biometrics Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
As a PK Scientist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-113203
Expiry date
01/01/0001
Author
Jeffrey VillasenorAuthor
Jeffrey VillasenorSalary
Location
India, Bangalore
Location
London
Bangalore
Bengaluru
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Data Standards Consultant
Job Type
Permanent
Description
We are currently seeking a Principal Clinical Data Standards Consultant to join our diverse and dynamic team. As a Clinical Data Standards Consultant at ICON, you will play a pivotal role in designing
Reference
JR118937
Expiry date
01/01/0001
Author
Sunidhi SinhaAuthor
Sunidhi SinhaSalary
Location
United States
Department
Biometrics Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
As a PK/PD Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-112014
Expiry date
01/01/0001
Author
Jeffrey VillasenorAuthor
Jeffrey Villasenor