Director of Clinical Data Management
Cambridge, MA
Clinical /
Fulltime /
Hybrid
Summary
The Director of Clinical Data Management plays a crucial role in facilitating the smooth creation and start-up of the electronic database, database cleaning and discrepancies management, and database lock of all oncology clinical studies at ARTBIO. This position requires skills in Medidata RAVE, CRO oversight, and prior experience with reconciliation of data coming from different databases (i.e. PK, IVRS, central lab, imaging vendor.) Prior experience working with RECIST and in an oncology phase 1 and 2 trial is a must. Ideally, this person also has some SAS programming skills. This individual will also need to have a basic understanding of MedDRA coding. The role will collaborate closely with the clinical operations teams, vendors, and investigative sites to support the efficient conduct of clinical trials.
Main Duties and Responsibilities
- Works with the clinical operations and development team to oversee data management activities with the CRO
- Day-to-day responsibilities include: creating and reviewing data listings, set up of EDC, ensuring edit checks are functioning, leading data cleaning activities and protocol deviation meetings with clinical operations and the clinical quality assurance groups, reviewing and managing data transfers between the CRO and ARTBIO, actively helping to reconcile data discrepancies during cleaning.
- Responsible for data specification documents ensuring data quality and compliance
Qualifications & Experience Required
- A university degree (Bachelors, Masters or higher qualification) in life sciences, computer science, or programming is required
- Minimum of 2 years’ experience in an industry role in data management is required (preferably in oncology)
Knowledge, Skills & Abilities Required
- Medidata RAVE
- Knowledgeable about RECIST 1.1 and MedDRA coding.
- SAS programming basic skills will be helpful but not a must
- Takes initiative
- Detail oriented
- Ability to adapt and contribute in a fast changing environment
- Executes on responsibilities independently
- Effectively interacts with internal and external parties within the context of a team
- Encourages and supports innovation
- Contributes to maintaining a positive company culture
- Acts as a role model for others in driving the company’s vision
Interpersonal Skills & Abilities
About Us
ARTBIO is a clinical-stage radiopharmaceutical company redefining cancer care by creating a new class of alpha radioligand therapies (ARTs). The unique ARTBIO approach selects the optimal alpha-precursor isotope (212Pb) and tumor-specific targets to create therapeutics with the potential for highest efficacy and safety. The company's AlphaDirect™ technology, a first-of-its-kind 212Pb isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing multiple pipeline programs with lead program AB001 currently in first in human trials. ARTBIO is shaped by a long-standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway’s Radium Hospital. For more information, visit www.artbio.com, and follow us on LinkedIn and Twitter.
As an emerging, global biotech with locations in Boston, Massachusetts, Basel, Switzerland, London, England and Oslo, Norway, we take advantage of diverse scientific depth and insights which makes ARTBIO a unique place to work. We are driven by a desire to do better for cancer patients, lowering the burden of toleration and safety while at the same time raising the bar on clinical efficacy and duration.
EEO Statement
ARTBIO is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.
