J&J Family of Companies Clinical Data Acquisition Lead (m/f) in Beerse, Belgium
Janssen Research & Development, L.L.C., a Johnson & Johnson Company, is hiring a Associate Director, Clinical Data Acquisition Expert Leader to be located in Antwerp (Belgium).
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
We’re looking for an
Clinical Data Acquisition Lead (m/f)
In this position, you will be 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 CDA-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 Delivery and cross functionally as necessary.
Provides leadership by attracting and retaining top talent, developing team members and ensuring organizational effectiveness, transparency and communications.
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.
Actively participate or lead Community of Practice, operational strategy and process recommendations
Provides supervisory support to direct reports, including coaching, mentoring, training, career development, priority setting, etc.
Provides strategic input into departmental staffing and/or sourcing strategy and ongoing evaluation of staffing/sourcing model.
Ensures compliance with department SOPs, policies and regulatory guidance documents.
Coordinates with other Operations Functional Leaders, Value Stream Leads and colleagues to ensure alignment of departmental roles and responsibilities.
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.
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
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 DDA, IDAR, and GCO, etc.
Ensures quality and compliance is monitored for deliverables, may provide input into the establishment of metrics.
Takes a leadership role in process improvement initiatives as appropriate. Collaborates to create strategies and best practices to increase efficiency.
A Bachelor’s Degree and minimum of 8 years’ relevant experience OR a Masters/MBA and a minimum of 6 years’ experience OR a PhD with post-doc experience and 4 years in a leadership function in clinical data management or statistical/data management programming with expert knowledge required in at least one of the two areas is required.
Expert project management skills and knowledge of team management principles are required.
Excellent people leadership skills and people management experience of 3 to 5 years is strongly preferred.
Knowledge of SAS programming skills or other analytical programming language is required.
Knowledge of eDC systems, e.g. Medidata platform of tools, Clinbase eCOS, etc. 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.
Understanding of data management and programming practices and systems is required.
A knowledge of regulatory guidance documents such as ICH requirements, inter-departmental processes, and relevant Clinical R&D concepts is required.
Knowledge of cross-functional working environment and industry trends that have an effect on departmental resources is required.
Knowledge of sourcing strategies, resource management, and organizational impact is required.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion, Janssen Research & Development, LLC is proud to be an equal opportunity employer.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Janssen Pharmaceutica N.V. (7555)
Clinical Data Management