Lead Data Manager
PRA Health Sciences
Req #: 113812
Type: US-Northeast
|
|
|||||||
|
||||||||
Overview: As a Lead Data Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities: 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 Qualifications: 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.
Share this job:
