Associate Director/Director, Clinical Data Sciences
POSTED ON 1/8/2021CLOSED ON 3/15/2021
Mersana Therapeutics, Inc.Cambridge, MAFull Time
Job Posting for Associate Director/Director, Clinical Data Sciences at Mersana Therapeutics, Inc.
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 and oversee 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 a thorough understanding of the drug development process and previously have had project level experience as a clinical Data Manager in supportive and leading roles within an oncology clinical development setting. You would be expected to have significant experience using data management methodologies and technologies (e.g. data warehousing and electronic data capture).
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 highly 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 in leading roles
Proficiency with the clinical data collection and data review process
Significant experience with using data management methodologies and technologies
Deep understanding of the drug development process
Strong organizational skills and ability to collaborate with minimal supervision
Some aspects of responsibility for this position:
Perform data cleaning activities including processing queries, performing ongoing data review, identifying issues, data trends and tracking them through resolution
Create, review and approve study startup documents, eCRF/Database specifications, Edit Check specifications, Data Management Plan (DMP), UAT Plans, CRF Completion guidelines and other documentation as required.
Ensure achievement of major data management deliverables and milestones in coordination with other functions
Lead or contribute to subject matter expert working groups and presenting best practices at internal meetings
Management of vendors to ensure efficient, timely and thorough execution of respective clinical data management processes
Work in tandem with Biostatisticians and Statistical Programmers on various programming 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 10 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.