Sr. Project Manager, Data Management

Boston, MA

About Us

At MorphoSys, we are driven by our mission: More life for people with cancer. As a global commercial-stage biopharmaceutical company, we develop and deliver innovative medicines, aspiring to redefine how cancer is treated.

Living up to the origin of our name – Metamorphosis – we transformed from a leading R&D partner into a fully integrated biopharmaceutical company. After nearly three decades in Germany, the doors to MorphoSys US opened in 2019 in Boston to launch our first breakthrough cancer immunotherapy, MONJUVI® (tafasitimab-cxix) in relapsed / refractory diffuse large B-cell lymphoma (DLBCL).

Since then, we haven’t slowed down. Adding to our leading R&D capabilities in Germany, a second global development hub opened in Boston to accelerate our US Commercial capabilities. In 2021, we expanded our portfolio with the acquisition of Constellation Pharmaceuticals, and we are continuing to emerge as a leader and future powerhouse in hematology-oncology. Grow with us.

MorphoSys is headquartered in Planegg, German and has its U.S. operations anchored in Boston, Massachusetts, offering colleagues flexible work models in all locations. The MorphoSys Group has more than 500 employees. For more information, visit www.MorphoSys.com and follow us on LinkedIn and Twitter.

Position Summary

Sr. Project Manager, Data Management at MorphoSys US in Boston, MA will be responsible implementing all DM standard operating procedures (SOPs) related to interventional and non-interventional clinical trials in proprietary and partnered programs executed from MorphoSys US, aligned with MorphoSys AG SOPs and computerized systems. This includes SOPs for the development of Data Management Plans (DMPs), electronic Case Report Forms (eCRFs), Data Validation Plans (DVPs), eCRF completion guidelines and Data Review Plans (DRPs). Sr. Project Manager, DM will also be responsible for leading and developing strategies to further strengthen the MorphoSys Global Data Management group, fostering innovation and efficient implementation and knowledge sharing between MorphoSys US and MorphoSys AG, and developing and executing a comprehensive roadmap and strategy, including identification of future technology and assessing opportunities to drive operational efficiencies.

Job Duties:

  • Serving as a subject matter expert for DMs and supporting the design, documentation, testing and implementation of clinical data collection tools, both CRF and non-CRFs, using an EDC system and/or other data collection systems;
  • Working with the Team Lead Biostatistics & DM, US to develop and monitor the department strategic direction and its alignment with global company strategies;
  • Designing and developing a data warehouse for ingestion of clinical trial data and metadata from operational systems used in MorphoSys US and MorphoSys AG in compliance with global and local data protection regulations;
  • Overseeing the preparation and maintenance of all CDM-related SOPs and work instructions;
  • Applying knowledge of MorphoSys’ existing vendor landscape for efficient management and initiation of new clinical trial projects;
  • Setting-up and maintaining standardized processes for EDC Build, Edit Check Specifications, UAT and EDC Validation;
  • Peer-coaching personnel by providing appropriate training and recognizing those who make significant contributions to business objectives;
  • Identifying and implementing solutions to data management issues and concerns, including proactive prevention strategies based on metrics and forecasts;
  • Providing leadership and functional partnering with internal and external project teams;
  • Continuous budget planning and forecasting of projects; and
  • Monitoring progress of assigned clinical trials for successful CDM deliverables as per company goals and agreed timelines.

Minimum Education/Skills/Experience

  • Master’s Degree (or its foreign equivalent) in a life sciences field and/or Clinical Research, plus
  • 8 years of clinical data management experience in the clinical research industry with solid expertise in CDM operations and analytics; and

Experience, which may be gained concurrently, must include:

  • 3 years of experience managing CDM-related projects;
  • 2 years of experience managing and supervising internal and/or external project teams;
  • Experience preparing CDM-related forecasts and budgets;
  • Expertise in CDM-related budget and resource planning, and CRO management of preferred partners;
  • Experience leading standardization processes in CDM and evaluation of resource requirements;
  • Ability to create effective CDM outsourcing models and execute the models to meet business needs;
  • Experience signing Clinical Trial documents as “Responsible Trial Data Manager”;
  • Broad understanding of:
    • Clinical trials methodology, GCP and medical terminology, especially in the area of oncology and autoimmune diseases;
    • CDISC standards (CDASH and SDTM) and CDM Best Practices;
    • At least two of the following DM collection tools: Medidata RAVE, IBM CD or Viedoc; and
    • Data Science and Data Analytic techniques;
  • Proven leadership, collaboration and organizational skills with demonstrated ability to successfully manage simultaneous deliverable and meet deadlines;
  • Project management skills necessary to oversee work being done by external vendors.

Full-time; position is located at 470 Atlantic Ave., Suite 1401, Boston, MA 02210. Interested applicants should apply on-line at https://www.morphosys-us.com/us-careers. No phone calls please.

Culture & Benefits

As a full time, employee of MorphoSys US Inc., you will receive a comprehensive benefits package consisting of medical and dental, vision, life, disability and more.  We offer a competitive PTO and holiday schedule – giving you the time you need to recharge, along with a 401k retirement plan which allows you the opportunity to save for your future with an employer matching program.  Our culture is a collaborative work environment, and we believe the unique contributions each of us brings drives our success

EEOC Statement

MorphoSys US Inc. is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices.  We are committed to creating a diverse work environment with non-discrimination for all employees and qualified applicants without regard to race, color, religion, national origin, sex, protected veteran status or disability.