Data Management Lead

The DML is accountable for all Data Management aspects of the assigned compound and/or indication from initiation till closure of activities ensuring that clinical data completeness, accuracy and consistency meet the standards of quality for analysis and reporting to regulatory bodies, compliant with the local and global regulations. The CDML function includes Line Management responsibilities of a team of Clinical Data Managers (CDM).

Roles and

Responsibilities:

Take a leadership role with the CRO and other internal and external partners to establish, align and conform Data Management expectations for the assigned compound and/or indicationTake a leadership role for Data Management in the Clinical and indication Team, which is ultimately responsible to define the clinical development strategy supporting the Target Product Profile (TPP) across the lifecycle of a compound, starting with the preparation of the “First-in-Human” (FiH) clinical trial throughout “Registration” and post-approval clinical development activitiesParticipate in the creation and maintenance of the Clinical Development Plan (CDP) which is describing the clinical development strategy, comprising effective where possible innovative trial designsOversee risk identification and risk mitigation strategies for the CDP. Identify risks or deviations from plans and communicate to the Head of Data Management; to the responsible Program Leader (PL) and Management as appropriate, proactively provide solutions and oversee implementationSet quality expectations and timelines for Data Management deliverables and will regularly follow up on Data Management milestones. Ensure inspection readiness at all timesEnsure compliance with SOPs, company policies and regulatory requirements from trial start-up to trial close-outSet expectations, communicate in a transparent, clear way and motivate team members to work towards achieving the clinical goals in line with the OGSM and the cultural pillars

For the assigned compounds/indication(s) the CDML will:

Oversee the CRO selection and contract negotiationsSupport the Clinical Data Portfolio Lead in keeping the oversight of the clinical budget for the assigned indication/program, collaborate with the CDMs andStatisticians to make sure the budgets are prepared, reviewed and updated within the forecast timelines as agreed with the PL and finance. Ensure that the trials and assigned clinical activities are executed within the agreed budget. Pro-actively escalate to the PLContribute to development of the protocol for the sections relevant for Data Management (feasibility of data collection, adherence to industry and argenx standards, (interim) locks) and/or review of protocol versions

For the assigned trial(s) under the compound/indication, the CDML will:

Ensure oversight of all deliverables of activities outsourced to CROs as outlined in the SOW and described in the Data Management Trial Oversight plan, including, but not limited to:

Creation of data collection tools (EDC, DTAs for 3rd party vendors, EDC integrations)Creation of essential documents (DMP, UAT documents)Creation of submission ready clinical data package per regulatory agencies requirementsCreation of archival package of clinical data per argenx requirementsEnsure oversight of all activities related to Data Management:Ensure that Data Management essential documents are written in a timely manner and of such quality to allow the evaluation of the conduct of a trial and the quality of the data producedKeep track of project plan, budget, metrics and KPIs. Adjust project plan as needed in consultation with Head of Data Management, CDM, Data Management CRO and Clinical Team as appropriateEnsure consistency between trials on compound/indication levelLeverages learnings and shares best practices within the indication and department

The CDML will also participate in activities other than study-related:

Lead/participate in initiatives on process improvementsParticipate in regulatory inspections and company auditsLine Management of CDMs and full on-boarding of new direct reportsEnsure that assigned staff is adequately trained and that training is documentedMentor and enable the growth and development of assigned staffCollaborate with Clinical Data Portfolio Lead for own goal setting and goal review as well as of the direct reports

Skills and Competencies:

Able to work effectively within a team matrix as well as independentlyStrong communication and interpersonal skillsFluent in English (written and spoken)Able to motivate and manage team members with the ability to prioritize tasks and organize workload