Director Program - Clinical Data Management

Cookie Notice Title: Director Program - Clinical Data Management Company: Ipsen Innovation (SAS) 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 company's success. 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Job Description: Job Title: Director Program - Clinical Data-Management (CDM) Division / Function: Data Management, Standards & Systems / Global Biometry Manager's 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 vendor's 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