Director Program Clinical Data Management

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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Job Title:

Director Program - Clinical Data-Management (CDM)

Division / Function:

Data Management Standards & Systems / Global Biometry

Managers Job Title:

Head of Data Management Standards & Systems

Ipsen Job Profile:

Clinical Operations Systems & Data

Location:

Paris (FR) or London (UK)

WHAT - Summary & Purpose of the Position

The Director Program - Clinical Data-Management defines and monitors the implementation of the Data Management strategy of an Asset/Therapeutic Area i.e. development program in Ipsen portfolio.

He/She is responsible for providing data management and operational expertise of high-quality databases by external vendors in adherence to Ipsen standards and regulatory requirements meeting project timelines resourcing budget and through effective processes.

He/She ensures that the Data-Management strategy is consistent across studies from a given Asset to minimize data-management rework and related timelines/budget for submission to Health Authorities.

He/she is accountable for the Data Management deliverables and the key point of contact and representative for the whole program.

He/She follows the Asset Clinical Data-Management related budget and resources for the whole program including planning and re-evaluating needs on regular basis and reporting to the Head of Function in view of management at function level.

For the projects he/she is directly leading he/she is accountable for the Data Management deliverables as assigned (study project and/or submission). He/She ensures that the clinical data collected processed and reported are supported according to high quality rigorous objective and informative Data Management procedures and processes. He/She ensures that clinical databases / pooled databases in the project(s) are consistent with Ipsen data standards and presented to the analysis and reporting process in such a way the evaluation of data will withstand interrogation and examination by regulatory bodies.

He/She oversees external vendors for outsourced activities and is responsible for the corresponding deliverables (quality budget and timelines).

Ensure cross functionals and external stakeholders oversight of all related data management activities (GPS Director ClinOps EDC Vendor CROs Coder Vendor etc)

Lead and oversee integration of data for new acquisition.

He/She helps to introduce and develop patterns of work within Clinical Development to support and enhance the delivery of clinical data and achieve clinical excellence by encouraging a team-based approach.

The position includes hierarchical management of Clinical Data Management Lead(s) and/or Clinical Data Managers or any other function as needed in the organisation.

To support the Head of Data Management for the planning resourcing and management of clinical research personnel under program area of responsibility.

To drive changes in process for continuous improvement and adaptation to business model.

WHAT - Main Responsibilities & Technical Competencies

• Related to Study / Program / Asset Activities

• Organize and coordinate the Data Management activities of an Asset including program level and study level from clinical synopsis / protocol review to the clinical study report and up to clinical data submission when applicable.
• He/She follows the Asset Data-Management related budget and resources for the whole program including planning and re-evaluating needs on regular basis and reporting to the Head of Function in view of management at function level.
• Manage the budget aspect and potential change orders in relation with finance and Head of Function for the related Data-Management activities including planning commitment purchase order receipt of goods closing.
• Define and put in place a high quality timely and robust data management strategy for the project (e.g. data capture tool data delivery flow for submissions). Develop and implement project specific guidelines and support documentation
• Provide Data Management input and expertise to the Asset Team throughout the clinical development. Ensure that the Data Management activities related to collection processing and data transfers to the Ipsen data warehouse are conducted in compliance with best practices
• Lead to selection of external vendors by evaluating their ability to deliver in the context of Ipsen projects.
• Oversee the external vendors activities and deliverables and report on the status of Data Management tasks as needed to the Study Team and/or Clinical Project Team. Make sure that subcontracted activities are delivered in line with the project expectations (timelines quality and budget). Follows budget and potential change orders in relation with the Clinical Development Programs Department.
• Ensure compliance of the data management deliverables with Ipsen rules and standards (e.g. standard database within Ipsen data warehouse) and ensure that the requirements from the clinical study protocol and the statistical analysis are fulfilled
• Monitor the data quality completeness and trend between subgroups (e.g. between countries centres) at different pre-identified and agreed time point in a project corresponding to milestone such as data review DSMC interim analysis using tools such as those developed for risk based monitoring.
• Coordinate all necessary activities to reach in a timely manner the database lock milestone such as making sure that the last transfer is complete (included all external data randomization data coding SAE reconciliation is complete). Approve the DB lock as Sponsor.
• To actively contribute as data expert in the submission team

• Leadership / Management

• The position includes functional management as well as hierarchical management
• He/She manages the functional activities of the team members allocated to the projects.
• He/She collaborates with team members to drive strategic project decision-making and deliver on commitments to the organization.
• He/She manages the functional activities of the team members allocated to the project.
• For hierarchical management: he/she is an effective team leader. Responsible for the recruitment the talent development provides line management and supervision of team members in his/her team including objectives definition appraisal review...
• The individual is responsible for building capabilities and technical skills within his/her group to ensure effective high-quality delivery.

• Processes and recommendations:

• Participate and/or Lead implementation of data quality systems and procedures and identify any needs for improvement.
• Perform new technologies intelligence and adapt to them as appropriate. Participate in the continuous improvement of the Data Management system in Ipsen.
• act as a SME main point of contact for due diligence activities and risk assessments with specific emphasis on the data management and data quality aspects for new acquisitions including leading the in-licensing agreements and new partner relationships.
• To analyse and recommend solutions to the head of Data Management Systems and Standards and any other Head of department within CDO and R&D on the organisation and participation in effective clinical trials programs.
• To provide expertise as required as a contributing as author in the development of department SOPs Working Procedures etc
• Review and approve key clinical documents CSR dry Run etc
• Participate and contribute along with procurement to SP selection & oversight meeting.

• EHS Mission / Duties to be performed of the site of Les Ulis:

• Conduct activities in accordance with rules and values of IPSEN.
• Within its sphere of activity to respect the regulation to apply the IPSEN good practices and standards and the SHE procedures set up on the site.
• Participate at the SHE training proposed in the framework of the training at post of work.
• Contribute to reduce the environmental impact of the activities on the site.
• Inform his / her superiors of any changes affecting the post of work so that the single document evaluation of occupational risks can be updated as well as any useful information to better take into account the EHS on site

HOW - Behavioural Competencies Required

Purpose Dedication
Safeguards data integrity and patient safety. Ensures decisions and data strategies support ethical conduct regulatory reliability and inspection readiness. Promotes a consistent quality and compliance culture across internal teams and vendors.

Thinking Dexterity
Connects study execution to asset and submission strategy. Anticipates risks affecting timelines standards and data flow and implements mitigation plans. Uses metrics and trend analysis to improve data quality efficiency and processes while introducing appropriate innovation and technology.

Social Agility
Collaborates effectively across Clinical Operations Biostatistics Programming Regulatory and external partners. Influences in a matrix environment manages challenging discussions constructively and adapts communication to technical and non-technical stakeholders.

Growing Self and Others
Leads coaches and develops Data Management staff. Sets clear expectations provides feedback and builds team capability in standards quality oversight and vendor management. Encourages ownership learning and knowledge sharing.

Being Intentional
Operates effectively in ambiguity and changing development environments. Communicates decisions clearly explains trade-offs and escalates risks when needed. Maintains focus and resilience under delivery pressure.

Making Real Impact
Delivers reliable inspection-ready databases on time and within budget. Holds teams and vendors accountable to performance standards. Drives continuous improvement and contributes clear data-based recommendations to program and submission decisions.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Ability to manage data management large projects: plan activities and tasks identify project constraints and dependencies identify and mitigate risks report on project status produce progress metrics and communicate efficiently with external vendors as well as internal partners
• To perform any other activity as may reasonably required by Head of Data Management from time to time.
• Ability to produce high quality accurate work to meet deadlines
• Ability to interact satisfactorily with staff of differing disciplines
• Well-developed time management communication presentation analytical and interpersonal skills
• Responsible flexible and accountable with a pro-active approach
• Ability to perform technical tasks and good understanding of clinical database structures and models
• Understand the basic needs of statistics and programming
• High level of expertise in the use of the data-management software
• Approximately 8-15 years of experience in a similar position with proven Project Management skills in Data-Management activities at a development program level

Knowledge & Experience (preferred):

• High knowledge of international standards (ICH GCP CDISC ) and regulations related to clinical studies electronic data capture and data management
• Experience of managing and developing relationships with Service Providers
• Experience of working with multidisciplinary groups and ability to work within a team environment.
• A good understanding of the drug development process
• Good budget management understanding
• Excellent organizational and management skills
• Excellent verbal and written communication skills.

Education / Certifications (essential):

• Life Science and/or Information Technology graduate

Language(s) (essential):

• English

Language(s) (preferred):

• French

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