Job Title: Specialist Clinical Data Acquisition Expert Leader
Location: UK (High Wycombe)
Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.
We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.
The Data Delivery Clinical Data Acquisition Expert (CDAE) Leader within Integrated Data Analytics and Reporting (IDAR) group is responsible for the management and development of approximately 9-15 direct reports.
The job holder is responsible for the development of a future proof data management technical capability with focus on building functional excellence, implementing and contributing to development of new data standards and adopting new technologies in support of delivering upon the assigned trial portfolio across therapeutic/business areas.
This is a management level position where problem solving and decision-making are expected and required.
The CDAE leader can take on additional roles such as being a business owner for processes or systems or acting as primary point of contact for a sourcing provider. The job holder provides significant leadership in the development of departmental policies, processes and trainings. The job holder will actively participate or lead a Community of Practice in order to align cross-functionally and across therapeutic areas.
The job holder will develop expertise in data collection methodologies, different data standard models from data capture through submission and will keep abreast with evolutions in industry trends.
This position makes decisions and recommendations that will have a direct impact on the project delivery, resource
allocation, and success of the overall delivery on the assigned portfolio. Decisions that are made by this position will also impact IDAR cross-functionally.
The CDAE Leader will effectively co-ordinate and manage Clinical Data Acquisition Experts and is accountable for recruiting, resource planning, management and development of all employees to meet current and future business needs. The CDAE Leader will communicate current and future strategy within Data Management and cross functionally as necessary.
1. Provides leadership by attracting and retaining top talent, developing team members and ensuring organizational effectiveness, transparency and communications.
2. Provides leadership in establishing operational strategy and process/system recommendations.
3. The individual is responsible for the performance management, development salary administration for direct reports, staff recruitment and will make decisions appropriate to this type of oversight and management.
4. Actively participate or lead Community of Practice, operational strategy and process recommendations
5. Provides supervisory support to direct reports, including coaching, mentoring, training, career development, priority setting, etc.
6. Provides strategic input into departmental staffing and/or sourcing strategy and ongoing evaluation of staffing/sourcing model.
7. Ensures compliance with department SOPs, policies and regulatory guidance documents.
8. Coordinates with other Data Management Leaders, Therapeutic Data Management Heads and peer colleagues to ensure alignment of departmental roles and responsibilities.
9. This position influences managers in decisions in terms of performance management of direct reports as appropriate and understands and aligns with long-term business and development needs.
10. Can Serve as a business owner for processes/systems of medium/high complexity and/or significant departmental or cross-functional impact. The individual is responsible for seeking input and making strategic decisions regarding the development, execution, and maintenance of the process/system in collaboration with the others
11. Leads departmental projects and implements solutions in collaboration with others. Identifies opportunities, evaluates and gives input on solutions to enhance efficiency and knowledge-sharing within Data Management, Clinical Data Standards, Statistical Programming, Global Clinical Operations, etc..
12. Ensures quality and compliance is monitored for deliverables, may provide input into the establishment of metrics.
13. Takes a leadership role in process improvement initiatives as appropriate. Collaborates to create strategies and best practices to increase efficiency.
the CDAE Can act as a primary point of contact for sourcing providers being responsible for establishing a strategic partnership, ensuring adherence to contract agreements, following up on capacity management, deliverables and compliance in close collaboration with other business partners and procurement.Qualifications
- A Bachelor’s degree with a minimum of 8 years of relevant
experience OR a Masters/MBA and a minimum relevant experience OR
a PhD with post-doc experience with a minimum of relevant experience
- Experience in either a leadership function in clinical data
management or statistical/data management programming with expert knowledge is required
- Excellent people leadership skills, people development practices,
and a minimum of people management experience is strongly required
- Understanding of data management and programming practices and
systems is required
- Knowledge of regulatory guidance documents such as ICH
requirements, inter-departmental processes, and relevant Clinical R&D
concepts is required
- This role requires knowledge of sourcing strategies, resource
management, and organizational impact
- knowledge of project management required
- Knowledge related to talent
development and relevant personnel policies and procedures is required
- Knowledge of cross-functional working environment and industry
trends that have an effect on departmental resources is required
- Knowledge of SAS programming skills or other analytical programming
language is required
- Knowledge of at least one eDC systems, e.g. Medidata
platform of tools, is required
- In-depth knowledge of
reporting tools (e.g. Spotfire) is required
- Expert knowledge of SDTM
including Define.xml, CDASH, metadata and ADAM is required
- Excellent leadership,
decision-making skills and proven ability to foster team productivity and
- Ability to operate and
execute with minimal supervision is required
- Strong technical and
analytic skills are required
United Kingdom-England-High WycombeOrganization
Janssen Cilag Ltd. (7360)Job Function
Clinical Data ManagementRequisition ID