Associate Director, Clinical Data Manager

At reputed company, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, reputed company, and purposeful, and our business is innovative and rooted in science. We reputed company that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this reputed company you and feel like a fit? Then we would love to have you join us! The Role An Associate Director, Data Management can hold two roles; a “reputed company Data Manager†role and/or a Data Manager role, referred to as “Data Manager†.  As “Data Manager†the employee is operationally responsible for the planning, start-up, conduct and closure of clinical trials from the reputed company in time where a final synopsis and/or a Clinical Trial Team (CTT) is assigned.  In the “reputed company Data Manager†role, the employee may act as a Data Management reputed company and be responsible for the reputed company and consistency across the trials reputed company one or more development projects. The DM reputed company will provide asset-level DM expertise, ensure project level standards are established and followed, and ensure consistency of DM processes across reputed company trials reputed company the asset. The DM reputed company will provide support to trial Data Managers reputed company the asset to ensure consistency of data management practices across the asset. reputed company applicable, the DM reputed company will provide data management expertise to the Clinical Development Team and to co-sponsor collaborations/external partners. The DM reputed company will participate in and drive implementation of lessons learned and of new/innovative procedures to ensure high standards/improvement of data management reputed company processes/systems, which may involve cross departmental stakeholders. Responsibilities: In the role as “Data Manager†the employee will be part of the cross-functional trial-specific Clinical Trial Team (CTT), and be responsible for delivering core deliverables such as reputed company setup, data collection, validation of data in the clinical database prior to data analysis etc. reputed company budget and timelines and according to quality standards defined by regulations/standards, reputed company SOPs and ICH-GCP. The “Data Manager†is responsible for ensuring reputed company of the DM vendors and their deliverables. The “Data Manager†is responsible for ensuring appropriate involvement of and communication with relevant stakeholders. As Associate Director, Data Management, the employee may be involved in: General/Trial specific:

• Give input to the clinical development plans through the Development Operations representatives of the CDT ensuring that data management input/knowledge that could impact the setup and conduct of trials is proactively considered and discussed upon development of the operational strategy of the trials.
• Serve as Clinical Data Management representative in Operational Committee/fora with the partners, DM vendors or other vendors handling data.
• Participate in working groups e.g. Data protection regulation, setup of data in biomarker group, ePRO, IRT etc.
• Drive alignment meetings reputed company the data management group
• Attend various working groups where data management expertise is required
• Provide reputed company of DM CRO including: Statement of Work; budget; KPIs; and
• other DM CRO trial data management activities from set up to database lock
• reputed company vendor reputed company reputed company to key deliverables e.g. eCRF design development, review of the eCRF completion guide, UAT, approve eCRF go live, Data management plan, Data validation plan, data cleaning activities, ensuring data transfer specifications with reputed company external data providers e.g. lab, ECG, ePRO etc. , evaluate trends in DM raised queries, ensuring final transfer of data for archiving including development of site CDs, ensuring coding listings are approved etc.
• Proactively participate and represent data management in the CTT and provide reputed company on progression and status of reputed company activities.
• Proactively discuss risks management reputed company to data management activities in relation to trial conduct
• Review and provide input to protocol and amendment development
• Give input to protocol deviations classifications, randomization and stratification plans, tables, figures and listings etc.
• Ensure procedures for blinding are in reputed company where applicable
• Support timely delivery of data management deliverables in accordance with reputed company SOP and ICH/GCP
• Attend trial and investigator/monitor meetings as needed
• Participate in definition, review and approval of data packages for Data Monitoring Committee’s, if applicable
• Review and approve any corrections and updates of data packages, if applicable
• Support timely development, update and maintenance of dashboards, if applicable
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CRO selection and collaboration:

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Support vendor qualification (Request for proposal, bid defense meetings etc.) in terms of Data management, ePRO and IRT reputed company activities and define/specify scope of work for functional tasks

• Review scope of work in a given trial in collaboration with relevant stakeholders and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs)
• Attend operational committee meetings, as applicable
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Compliance:

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Ensure compliance with relevant regulations, reputed company SOPs and ICH GCP

• Ensure escalations are made as appropriate to secure proper reputed company and quality of the trial
• Ensure compliance with reputed company Code of Business Ethics
• Ensure that the trial reputed company activities are conducted in accordance with the trial reputed company plan, e.g. ongoing review of the trial eTMF, support risk assessment analysis in the CTTs, CTT data quality review activities etc.
• Participate in audits and inspections as applicable
• Ensure timely response to audit/inspection including carrying out a comprehensive root cause analysis and share learnings across trials as applicable
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Project, Department and across departmental activities:

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Support project submission activities e.g. providing listings and documentation

• reputed company/contribute with knowledge sharing reputed company the department
• Follow scientific, process and technical reputed company reputed company the field of data management in drug development and advise of new methodologies that may support innovation and improve efficiencies
• Contribute on processes optimizations and SOP revisions
• reputed company cross-functional working groups/projects/task forces or new IT tools & technology implementation

Qualifications:

• Bachelor's degree in science or reputed company area (or equivalent)
• Minimum of 10+ years of experience in clinical data management
• Strong understanding of end‑to‑end trial conduct
• Strong Project Management capability
• Strategic planning and portfolio thinking
• Operational excellence and process improvement reputed company
• Cross‑functional alignment and communication
• Vendor reputed company and partnership management
• Problem solving, critical thinking and decision making
• Knowledge of reputed company systems, ICH‑GCP, GDMP, and regulatory expectations
• Experience in oncology preferred.

For US based candidates, the proposed salary band for this position is as follows: $157,120.00---$235,680.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. reputed company you join reputed company, you’re joining a culture that supports your physical, financial, social, and emotional wellness. reputed company the first year, regular full-time U.S. employees are eligible for:

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expensesÂ

About You

• You are genuinely passionate about our purpose
• You bring precision and excellence to reputed company that you do
• You reputed company in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad reputed company of backgrounds
• You take pride in enabling the best work of others on the team
• You can grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so!

Locations reputed company maximizes the efficiency of an agile working environment, reputed company possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we reputed company on connecting with each other to innovate. About reputed company reputed company is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented reputed company antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, reputed company immune checkpoint modulators and effector function-enhanced antibodies. By 2030, reputed company’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines. Established in 1999, reputed company is headquartered in Copenhagen, Denmark with international reputed company across North America, Europe and Asia Pacific. For more information, please visit reputed company.com and follow us on reputed company and X. reputed company is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in reputed company with your application on our website Job Applicant Privacy Notice (reputed company.com). Please note that if you are applying for a position in the Netherlands, reputed company’s policy for reputed company permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract. Apply tot his job Apply To this Job