Senior Clinical Data Manager

At Genmab we are dedicated to building extranotordinary 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 candid and purposeful and our business is innovative and rooted in science. We believe 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 inspire you and feel like a fit Then we would love to have you join us!

A Senior Data Manager can hold two roles; a Lead Data Manager role and 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 Provide oversight of the DM CRO and ensure performance against key indicators.

As Lead Data Manager the employee may act as project Data Manager and be responsible to oversight and ensure consistency cross more trials within one or more development projects. The Lead Data Manager will participate in and drive implementation of lessons learned and new innovative procedures to ensure high standards/improvement of data management related processes and systems which may involve cross departmental stakeholders. The employee may represent Clinical Data Management in Operational Committees/fora with the partners and/or DM vendors.

As Senior Data Manager the employee will support /train colleagues in and advise on handling of data management related processes/issues and may act as a mentor. Moreover the employee shall support the overall strategy and development of Clinical Data Management by attending/leading task force initiatives within the department and/or as part of cross-departmental teams.

Roles and 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 EDC setup data collection validation of data in the clinical database prior to data analysis etc. within budget and timelines and according to quality standards defined by regulations/standards Genmab SOPs and ICH-GCP. The Data Manager is responsible for ensuring oversight of the DM vendors and their deliverables.

The Data Manager is responsible for ensuring appropriate involvement of and communication with relevant stakeholders. As Senior Data Manager 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 within the data management group

• Attend various working groups where data management expertise is required

• Perform vendor oversight related 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 all 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 oversight on progression and status of related activities.

• Proactively discuss risks management related 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 place where applicable

• Support timely delivery of data management deliverables in accordance with Genmab SOP and ICH/GCP

• Attend trial and investigator/monitor meetings as needed

• Participate in definition review and approval of data packages for Data Monitoring Committees if applicable

• Review and approve any corrections and updates of data packages if applicable

• Support timely development update and maintenance of dashboards if applicable

CRO selection and collaboration:

• Support vendor qualification (Request for proposal bid defense meetings etc.) in terms of Data management ePRO and IRT related 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

Compliance:

• Ensure compliance with relevant regulations Genmab SOPs and ICH GCP

• Ensure escalations are made as appropriate to secure proper progress and quality of the trial

• Ensure compliance with Genmab Code of Business Ethics

• Ensure that the trial oversight activities are conducted in accordance with the trial oversight 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

Project Department and across departmental activities:

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

• Lead/contribute with knowledge sharing within the department

• Follow scientific process and technical progress within 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

• Lead and participate in cross-functional working groups/ projects/task forces

Requirements:

• Bachelors degree in science or related area
  5-8 years of experience in clinical data management in biotech/ pharma industry; significant hands-on end-to-end experience in clinical data management practices.

• Experience within oncology trials highly preferred

• Experience with clinical trials and the drug development process

• Significant experience leading data management activities for multiple clinical trials; proficient use of data management systems; advanced knowledge of DM processes tools methodologies and documentation; strong understanding of DM strategy

• Experience and understanding of GCPs SOPs regulatory requirements and good data management practices

• Project management experience

Competencies:

• The Employee must have competences within the following areas:

• Planning and organization

• Clinical development/trial conduct including ICH-GCP

• Team leadership

• Problem solving and decision making

• Good communication skills and able to communicate scientific communication in clear and concise manner

• Quality mindset

• Document creation and management

• Process development

• Proactive and Accountable

• Analytical and ability to interpret and present clinical data

• IT skills (proficiency with data management systems)

• In-depth knowledge of regulatory guidelines (e.g. FDA EMA ICH) and industry standards for clinical data management.
  

For US based candidates the proposed salary band for this position is as follows:

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.

When you join Genmab youre joining a culture that supports your physical financial social and emotional wellness. Within 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 expenses

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum 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

Genmab maximizes the efficiency of an agile working environment when 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 youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.

About Genmab

Genmab 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 next-generation antibody technology platforms and harnessed translational quantitative and data sciences resulting in a proprietary pipeline including bispecific T-cell engagers antibody-drug conjugates next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030 Genmabs 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 Genmab is headquartered in Copenhagen Denmark with international presence across North America Europe and Asia Pacific. For more information please visit and follow us on LinkedIn and X.

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Please note that if you are applying for a position in the Netherlands Genmabs policy for all 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.

Required Experience:

Manager