Director Operations - Clinical Data Management

Job description

Title: Director Operations - 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. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram. Job Description: Job Title: Director Operations - Clinical Data-Management (CDM) Division / Function: Data Management, Standards & Systems / Clinical Development Operations Location: Paris (FR), London (UK), or Boston (US) WHAT - Summary & Purpose of the Position The Director Operations - Clinical Data-Management is responsible for the management of critical, trial and non-trial specific activities and functions that support the Clinical Data Management organization. He/She is responsible for leading the development of and oversight of administrative and trial and non-trial operations to help ensure Ipsen and Ipsen CDM meet or exceed Ipsen goals and objectives, maintain regulatory compliance, and effectively work with strategic partners. He/She is an integral part of the CDM leadership team helping define and execute near and longer term strategies in collaboration with CDM and Ipsen leadership. WHAT - Main Responsibilities & Technical Competencies Non-trial, administrative operations responsibilities Define, implement, and oversee Quality Management (QM) within CDM. This includes, but is not limited to:Creating and implementing a QM framework in CDM that defines quality goals, processes and KQIs; Working collaboratively with Quality Assurance (QA) so that the QM framework works harmoniously and efficiently with QA processes and procedures; Working with QA and CDM Operations to ensure quality findings, CAPAs, audit or inspection reports or findings, or other quality-related actions are completed on time; Ensuring CDM-related documents are appropriately filed in the Trial Master File (TMF) by collaborating with QA, Ipsen CDM, and external partners. Works collaboratively with Asset Data Management leaders, Talent Acquisition (TA), and external vendors and partners to identify and secure personnel resources. This includes, but is not limited to:Creating and managing a resourcing requirement model or tool that evaluates needs on an ongoing basis; Establishing a process to secure the right people at the right time and communicating status of the resourcing requests to stakeholders; Devising a mechanism to manage peaks and troughs in resourcing needs to ensure deliverables are met. Manages the CDM documentation environment such as Standard Operating Procedures (SOPs) and other working guidelines, procedures and processes. This includes, but is not limited to:Ensuring the correct SOPs, etc., are in place to meet regulatory requirements while providing guidance to CDM staff and partners on how to conduct Ipsen CDM trials; Periodic review and revision of CDM documentation; Distribution, training, and oversight of training compliance with SOPs, etc., as they are developed or revised; Creating, implementing and overseeing a model to evaluate SOP compliance by CDM staff through methods such as review of training records, periodic assessments or audits, and trial-specific / team-specific / vendor-specific “spot checks.” Direct change management activities within CDM. This includes, but is not limited to:Establishing a change management methodology to be used within CDM including strategy, framework, project management of initiatives, measurement of status and success, and communications; Promoting and advocating a change management mindset across CDM; Developing and leading change management initiatives and projects as defined by the CDM leadership team, whether they are driven by cultural, process, technical or other origin; Working collaboratively and effectively with broader change management leaders at Ipsen; Participating in and aligning with broader Ipsen change management initiatives as necessary; Collaborating with partners to leverage their expertise and support with Ipsen CDM change management initiatives. Participate in operational governance with external partners. This includes, but is not limited to:Working directly with partners on initiatives such as change management, resourcing, process changes; innovation, KPIs/KQIs/metrics, etc., as assigned; Participating in operational governance meetings and executive governance meetings as requested. Track, manage, and report on CDM KPIs, KQIs, and other metrics. This includes, but is not limited to:Establishing and overseeing a strategy on which metrics to collect, target setting, collation methodology, reporting frequency and distribution, and result analysis and action planning; Working collaboratively with internal CDM, internal Ipsen and external partners to gather data; Analysing and reporting outcomes to stakeholders; Defining and executing action plans based on outcomes. Contribute to innovation initiatives as requested. This includes, but is not limited to:Working collaboratively with Ipsen CDM leadership and external partners to strategize on innovation; Participating in innovation initiatives as directed which may include, but not limited to:Project management Change management Process changes, documentation changes, training, and adoption oversight KPI, KQI, metrics, and ROI tracking Aligning with broader Ipsen innovation initiatives potentially including representing Ipsen CDM Manage Ipsen CDM training environment. This includes, but is not limited to:Collaborating with Ipsen CDM leadership to define CDM training framework; Working with QA and other Ipsen functions to align CDM training with Ipsen standards; Oversight of, and reporting on, internal Ipsen CDM and external partner training compliance; Collaborating with internal stakeholders and external partners to identify new training needs due to new or revised regulations, changes in technology, processes, or operating model, etc.; Identifying methods to improve delivery and comprehension of training materials. Other administrative, operational assignments as requested. Trial / Study-related responsibilities Direct management of Ipsen CDM resources that are “pooled” across therapeutic areas including coding and data cleaning when that work is done “in-house” by Ipsen CDM. Ensure study timelines and deliverables are met by team members with quality. Work collaboratively with Ipsen CDM leadership to ensure appropriate resourcing, study expectations, deliverables, and timelines are understood and achieved. Leadership / Management Responsible for the recruitment, talent development, line management and supervision of team members in his/her team including objectives definition, appraisal review, and performance management. Responsible for building capabilities and technical skills within his/her group to ensure effective, high-quality delivery. Member of the Ipsen CDM Leadership team, successfully participating and executing responsibilities as assigned by the Ipsen Head of DMSS. 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. Promote