Team Lead - Clinical Data Management
Summary
Leads a team managing clinical trial data, ensuring compliance with regulations and SOPs while overseeing database design, validation, and team performance in the healthcare domain.
About the role:
The Team Lead Data Management will have responsibility for Data Management staff as assigned and ensures that line reports conduct clinical trials according to all applicable Good Clinical Practice (GCP), Regulatory Requirements, Standard Operating Procedures (SOPs) and the Project Agreement.
Minimum Qualifications & Experience:
A degree in clinical, biological or mathematical sciences or related field, with a minimum of 4-6 years of relevant work experience.
Advanced knowledge of Data Management processes and systems.
Outstanding written and oral communication skills are required. • Solid understanding of clinical drug development process is preferred.
Proven leadership skills and the ability to lead by example and to encourage team members to seek solutions.
Previous people management experience is preferred.
Excellent organizational skills and demonstrated ability to manage projects.
Experience in effectively managing multiple tasks simultaneously.
Effective problem-solving skills.
Experience in the creation of new processes.
Responsibilities:
Line Management
Manage a team of professional Data Management staff.
Define and prioritize resource requirements and manage resource assignments across projects.
Actively contribute to recruitment of new staff.
Review and prioritise resource allocation on projects, liaising with CDM/PM as required.
Ensure on-boarding, training and integration of all new line reports and that process is completed as per company policy.
Ensure that they understand the company policies and procedures appropriate to their position.
Meet regularly with line reports. Review and manage their workload, welfare and developmental needs.
Performance management of line reports; set and agree written goals and objectives, competency assessments, coordinate salary reviews and promotions and maintain succession plans.
Review and approve leave requests, timesheets etc. in line with company policies.
Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers.
Understand scope of work, budget, and scope assumptions.
May be Project Manager/Project Lead for major study or a series/group of studies.
Provide support in creation and review of proposals and change orders.
Biometrics Support Management
Support the delivery of consistent training and development of line reports in order to develop growth and promotion from within the Data Management group.
In collaboration with the Project Management and CDM function, identify and implement opportunities for better support of project teams by the line reports.
General
Ensure adhere to Company policies, procedures and guidelines and be quality minded in performance of duties.
Assist in the review and development of Novotech SOPs and guidelines.
Identify areas of inefficiency and make recommendations for improvements.
Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties and the performance of the Data Management team presents a positive professional image of the company.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working in clinical research and biotech, including people who identify with LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to responding to every application. We look forward to talking to you about working at Novotech.
Responsibilities:
The Team Lead Clinical Data Programming (CDP) is responsible for providing technical, procedural (SOPs) and planning leadership across multiple projects assigned to the CDP team members ensuring that they deliver in accordance with SOPs, programming best practices, and the timelines agreed within the Project Team.
- Assist CDP team members in detailed project planning in accordance with SOPs and project specific requirements. Participate in Client and Project meetings as required to explain the CDP requirements, process and through-put times.
- Undertake trouble shooting at project, procedural and technical levels. Liaise with data management, statistical and clinical teams to ensure efficient operations and problem resolution. Liaise with internal Biometrics specialised teams to resolve issues affecting timely completion of CDP deliverables. Escalate issues to Manager CDP and Director CDP, as required.
- Assist Manager CDP in frequent resource forecasting and (re-) assignment of team members to projects and/or CDP tasks. Allocate projects’ CDP tasks appropriately among assigned resources to achieve target utilization rates of each resource. Flag staff performance and resourcing issues to Manager CDP and Director CDP, as required.
- Undertake quality and technical reviews of team members’ critical CDP deliverables as part of database builds, database migrations, database lock and database decommissioning activities, as well as CDP filing of critical documentation required in the TMF.
- Ensure adherence of staff to SOPs, Forms, and Best Practice Programming conventions.
- Undertake or assist team members with all CDP programming database tasks, especially during project Start-up and as part of the impact analysis of change requests affecting the database design including supervising database migrations.
- Undertake troubleshooting of software issues in projects with EDC vendors via the EDC Vendor’s Help Desk. Escalate business critical issues requiring immediate resolution to Manager, CDP, for further escalation within the EDC vendor.
- Provide training and mentoring to new and existing CDP team members in SOPs, software applications, and programming best practices including use of standardised CRFs, edit checks, programs from the available generic and disease specific libraries.
Minimum Qualifications & Experience:
Graduate in information science or life science related field, or similar. More than four years’ experience in a Senior Clinical Data Programmer role in a pharmaceutical company, CRO or EDC software provider, including supervision and training of other programmers.