Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.
We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.
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 indication
- Take 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 activities
- Participate in the creation and maintenance of the Clinical Development Plan (CDP) which is describing the clinical development strategy, comprising effective where possible innovative trial designs
- Oversee 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 implementation
- Set quality expectations and timelines for Data Management deliverables and will regularly follow up on Data Management milestones. Ensure inspection readiness at all times
- Ensure compliance with SOPs, company policies and regulatory requirements from trial start-up to trial close-out
- Set 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 negotiations
- Support the Clinical Data Portfolio Lead in keeping the oversight of the clinical budget for the assigned indication/program, collaborate with the CDMs and
- Statisticians 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 PL
- Contribute 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 requirements
- Creation of archival package of clinical data per argenx requirements
- Ensure 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 produced
- Keep 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 appropriate
- Ensure consistency between trials on compound/indication level
- Leverages 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 improvements
- Participate in regulatory inspections and company audits
- Line Management of CDMs and full on-boarding of new direct reports
- Ensure that assigned staff is adequately trained and that training is documented
- Mentor and enable the growth and development of assigned staff
- Collaborate 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 independently
- Strong communication and interpersonal skills
- Fluent in English (written and spoken)
- Able to motivate and manage team members with the ability to prioritize tasks and organize workload
- Natural Leader with the ability to work independently
- Strong people management skills, leader and team player
Education, Experience and Qualifications:
- Bachelor’s degree or Master’s degree – medical, para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.), mathematics or equivalent by experience
- Demonstrated experience in Clinical Data Management and in managing CROs and vendors
- Biotech experience is a plus
- Auto-immune and/or orphan disease clinical study background is a plus
- Line management experience is a plus
Note: The recruiter will share the locally applicable annual base salary hiring range, provided in your country’s currency, during the recruitment process. This information will reflect market conditions, role scope, and internal guidelines specific to your location.
This job is eligible to participate in our short-term and long-term incentives program.
The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.
At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
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