Biometric Systems Manager F/M

Summary / purpose of the position
The   Biometric Systems Manager drives successful implementation and use of clinical data management systems (CDMS) and Statistical Computer environment (SCE) in relation to planning, Implementation, Adoption & Maintenance.
The Biometric Systems Manager delivers projects working multidisciplinary teams such as data management, Stats programming, clinical trial excellence team, quality, IT.
He/she manages these biometry systems in compliance with Regulatory, GXP and Business requirements integrating Ipsen processes to ensure internal worldwide deployment, driving a culture of compliance and quality that aligns with ICH/GCP guidelines, regulatory requirements, and internal policies.

Duties include analyzing Biometry Leadership and user requirements, assigning appropriate internal or external resources, overseeing planned and ongoing work to a successful and on time outcome, managing financial requirements and maintaining the highest level of quality. Also, duties include monitoring changes in the business environment, analyzing the Ipsen needs in perspective with new capabilities and proposing roadmap to maintain up-to-date systems and corresponding services.

Main responsibilities / job expectations 
System Planning, Implementation, Adoption & Maintenance 
•    He/she is responsible for the technical management of all Biometrics systems. 
•    Support the development of efficient implementation and adoption plans.
•    Ensure the proper operation of the systems, including compliance to specifications, performance and support.
•    Initiate continuous improvement efforts, identify, and develop best practices, and enforce standardization throughout system implementation.
•    Propose system upgrade and contribute to the projects when approved
•    Ensure implementation and maintenance of the GxP validation status when applicable with IT QA. This includes making sure that validation-related activities are conducted by the team or under the team responsibility when systems are implemented or upgraded (risk analysis, UAT scripts development, UAT scripts execution, maintenance of the validation documentation).
•    Contribute to the security of the systems with IT security
•    Ensure compliance with applicable regulations including GDPR
•    Manage contracts renewals when appropriate
•    Lead Request For proposal process up to vendor selection and contract execution with vendor. 
•    Users training and business process definition are under System Owner responsibility who may be within the Systems, Standards and Services team.
•    In addition, the Biometric System Manager maintains competitive intelligence and monitor changes in the pharmaceutical industry environment. He/she analyzes the Ipsen needs, put in perspective with new capabilities and propose a roadmap to keep Ipsen Biometry systems up-to-date and on the top of the art when possible.
•    Monitor the use of the systems by performing periodic quality checks to identify compliance issues and areas where support and help are most needed.
•    Provide and monitor metrics and key system indicators (number of connections, etc.)
•    Oversight the service provider in charge of the system support.
•    Act as an active Change Advisory Board member providing recommendations for priority of any new enhancements/bug fixes.
Team management:
The  Biometric Systems Manager is an effective team manager, responsible for talent development, line management and supervision of team members in his/her group. He/she is responsible for building capabilities and technical skills within his/her group to ensure team efficiency.
He/She recruits, manages, mentors, trains, develops all Systems collaborators and conduct the RH processes including objectives definition, performance review, assessment of development needs. He/She manages the team priorities and its workload.
He/She defines and tracks the budget and the contracts associated to these activities and for temporary staff (if any).

Acquisition of new products or companies
• Support the assessment of similar systems/processes used by the acquired companies
• Support data integration strategy/plan
• Can take over for a transitional period the administration of an equivalent activity while waiting
for a convergence of the processes

EHS responsibilities:
• Comply with applicable EHS regulations and procedures.
• Participate in the site's EHS performance by reporting risks, malfunctions or improvements
• Participate in mandatory EHS training

Knowledge, abilities & experience
Education / Certifications: 
Bachelor’s degree in life sciences, information technology, or related field

Experience:
Successful experience in the implementation/management of biometric systems
Strong experience in GXP system validation processes
Demonstrate initiative, problem solving mindset, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneously.
Understanding of Information Security / data privacy principles to ensure compliant handling and management of data.
Ability to develop and implement a system implementation strategy.
Experience in oversight subcontracting activities with a vendor
In-depth knowledge of international standards (ICH, GCP) and other regulatory and legal requirements having an impact on the development and maintenance of systems used in clinical development.
Collaborative team player, professional demeanor, enthusiastic, and self-motivated
Ability to work effectively in a matrix organization.
Ability to communicate effectively with senior management as well as with peers
Excellent oral and written communication skills.
Ability to produce high quality, accurate work to meet deadline. (Strong planning skills)

Languages: Fluent English
Key Technical Competencies Required
Good knowledge of international standards (ICH, GCP, GAMP …)
Good knowledge of systems used in drug development (SAS, Datawarehouse, Data Lake, CDMS)
Up to date on regulations regarding clinical data collection such as: GCP (Good Clinical Practice), 21 CFR part 11,
GCDMP (Good Clinical Data Management Practices) and GDPR (General Data Protection Regulation)
Good experience in validating GXP systems
Good knowledge of project management methods
 

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