Senior Manager, Clinical Programming

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!

The Role

The Senior Manager Clinical Programming is responsible for the establishment governance and integrity of Study Data Tabulation Model (SDTM) standards perform sponsor oversight of relevant programming activities on the Biometrics vendor ensure the quality and consistency of data standards to support the portfolio towards the ultimate objective of data quality and consistency across programs and systems.

Responsibilities

Develops and implements company Study Data Tabulation Model (SDTM) standards that support the scientific need of a study/program while ensuring quality consistency and compliance to CDISC standards and other industry standards that supports the exchange of data reporting and analysis.

Ensures alignment of SDTM standards with data collection standards and relevant company tools/system requirements by reviewing study eCRFs supporting creation of external data collection standards and providing SDTM mapping guidance

Serves as a subject matter expert on all aspects of standards development that includes industry standards (CDISC) regulations and processes

Ensures study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements reviews study submission data packages to ensure quality and integrity

Directly supports knowledge development of others as a subject matter expert on data standards reporting and analysis standards change control management and related tools/applications

Creates quality control processes metrics and other measures to ensure compliance with standards

Ensures work carried out in accordance with applicable SOPs and working practices as well as global agency regulations/guidances

Creates any needed documentation and training for standard processes change control management and tools

Responsible for defining standards specifications working closely with implementation support teams (database set-up completion guidelines CRF designers procedures algorithm specifications and reporting requirements)

Facilitates a culture of continuous process improvement and a high level of customer service by maintaining and improving the standards processes associated with standards creation maintenance decision-making and implementation

Working with Digital Solutions and IT support the implementation of future strategies and technology-enabled processes and tools for clinical trials standards change control management and the exchange of standards information to internal downstream consumers and externally consumers

Serves as a liaison between Clinical Programming and External Data Management to ensure data standardization alignment and proactively resolve external data issues that impact SDTM deliverables.

Requirements

Bachelors degree in Statistics Computer Science Life Sciences. Masters degree in Statistics Computer Science Life Sciences preferred

At least 6-8 years relevant experience in a pharmaceutical biotech CRO or Regulatory Agency

Proficient in SAS programming 6-8 years experience.

Practical knowledge and experience using R to support clinical trial preferred

Demonstrated knowledge of clinical research metadata management industry standards (CDISC) FDA & ICH GCP and related regulatory requirements

Demonstrated experience managing multiple tasks complex projects and working with cross functional teams delivering to project and portfolio timelines and metrics

Strong verbal and written communication skills; independent and effective working in a multi-study multi-disciplinary atmosphere in a matrix environment

Experience in clinical data management and/or trial management experience with technical expertise in standards management and implementationis preferred.

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.