What’s in it for you?
In this role, your work will help the advancement of new antibody-drug conjugate (ADC) therapies to treat patients fighting cancer, including ovarian cancer and non-small cell lung cancer. Specifically, you will contribute to the organization by utilizing your skills to conduct the execution of data management activities of assigned studies. You will be immersed in a learning organization, with a need to bring an open mind and an interest in mastering this new therapeutic space at a rapid pace.
You will be a member of the Clinical Data Sciences team nested within Clinical Development Operations and report to the Senior Director of Clinical Data Sciences. You will assist Mersana with building upon data management activities that drive innovation, teamwork and efficiency in support of our clinical pipeline. You will also form working relationships with members of Mersana’s Translational Medicine and Clinical Pharmacology teams, our contract research organization collaborators, and have the opportunity to hone your skills in these areas of research and data analysis.
To be successful, you will have an understanding of the drug development process and previously have had project level experience as a clinical Data Manager in supportive roles within an oncology clinical development setting. You would be expected to have experience using data management methodologies and technologies (e.g. electronic data capture and reporting).
How do you know if you’re the right fit?
This position would be a perfect fit if you are a skilled Clinical Data Manager with an urge to work within a highly motivated small team environment where your work is visible and impacting to the organization. If you are a self-motivated, driven individual who enjoys the challenges and opportunities available in a growing and transforming organization, such as crafting and implementing creative ideas to better collect, clean and report clinical data, this will be an opportunity for you to apply yourself, learn and deliver.
Your experience within the oncology therapeutic space should include the following to allow you to be successful within this position:
- Project level experience as a Data Manager
- Proficiency with the clinical data collection and data review process
- Experience with using data management methodologies and technologies
- Understanding of the drug development process
- Strong organizational skills and ability to collaborate with minimal supervision
Some aspects of responsibility for this position:
- Assist in the development and review of CDM study documentation, including Case Report Forms (eCRFs), Data Management Plans, Data Transfer Agreements, Data Review Guidelines and CRF Completion Guidelines
- Assist in the creation and review of study startup documents, eCRF/Database specifications, Edit Check specifications, Data Management Plan (DMP), User Acceptance Testing (UAT) Plans, CRF Completion guidelines and other documentation as required.
- Perform data cleaning activities including processing queries, performing ongoing data review, identifying issues, data trends and tracking them through resolution
- Review clinical study documentation including protocol, project timelines, meeting minutes, memos and study notes to file
- Participate in User Acceptance Testing for clinical study databases
- Work in tandem with Biostatisticians, Statistical Programmers and Medical Monitors on various tasks to support Mersana’s clinical projects.
The other stuff
This is typically a role best suited for those with a Bachelor or Masters’ level degree in human sciences who possess at least 5 years’ pharmaceutical/biotechnology/CRO experience.
In addition, the successful candidate will possess:
- A thorough understanding of FDA, GCP, ICH, and CDISC data handling standards and specifications
- Demonstrated strong analytical and strategic thinking skills
- Ability to program in SAS, desirable but not required
- Experience working with safety data and coding dictionaries (MedDRA and WHODD)
- Proven leadership, interpersonal, negotiating, and conflict resolution skills
Position is eligible for bonus, option awards and benefits including medical, dental and life insurance, 401(k) participation, paid vacation and paid holidays.
Successful candidate must be authorized to work in the United States.
Mersana Therapeutics, Inc. is an equal opportunity employer.