Clinical Data Associate

Scipher Medicine develops innovative diagnostic tests to determine drug response and targeted therapies using its proprietary personalized medicine platform based on molecular technology. Our platform allows us to interpret genomic data to gain unique insights into disease biology so patients with even the most complex diseases can achieve optimal health outcomes.

With only about 1 out of 3 patients adequately responding to anti-tumor necrosis (anti-TNF) therapies, the world’s largest selling drug class, we developed our flagship test, PrismRA™, to predict response to these drugs, thereby ensuring patients receive the most effective therapies from day one. Scipher is transforming the traditional diagnostics business model by working closely with payers to change the way medications will be prescribed, saving both insurers and patients billions wasted in ineffective prescription costs. This is a unique opportunity to join a promising venture at an early stage to tackle some of the biggest problems in healthcare.

We are proud of our passionate, high-performance, mission-driven culture – one based on a set of values that are the cornerstone of who we are and how we hold ourselves accountable. Founded in 2015, we are based in Waltham, MA and currently expanding across all functions within the organization. We are backed by Khosla Ventures, Northpond Ventures, Alumni Ventures and Tachyon Ventures, and are well capitalized to execute our vision of launching a personalized medicine platform that transforms patients’ lives. Check us out at www.sciphermedicine.com and follow us on LinkedIn.

The Role: The Clinical Data Associate will lead all data management activities for clinical studies, including the design, development, and management of electronic databases as well as the implementation of data management processes and plans to ensure the delivery of timely, quality, complete, and accurate data.  

Where: Waltham, MA.

What will I do?
-Lead the design and development of electronic databases for clinical studies
-Collaborate with internal clinical study team to ensure all stakeholders’ needs are addressed, and communicates project status and issues
-Develop electronic Case Report Forms (eCRFs), eCRF Completion Guidelines (CCGs), and Data Management Plans (DMP)
-Review all clinical data for completeness and accuracy and identify discrepancies
-Collaborate with the project team to address and resolve all data issues
-Review data analysis listings and create reports on performance and quality
-Review clinical data within studies and across programs for trend analysis
-Identify and implement solutions for clinical data issues or concerns
-Ensure database and data management processes meet project requirements
-Act as liaison with CROs, third party data vendors, and EDC vendors
-Accountable for external data vendor documentation, management, and reconciliation
-Participate in project and cross-functional team meetings
-Collaborate with the Clinical Operations team to ensure the data management component of the eTMF is maintained appropriately throughout the trial.

Minimum Education and Qualifications:
-Bachelor’s degree in a relevant field
-3 years of relevant work experience in clinical data management
-In depth knowledge of clinical data management, trial management, quality management, and system applications to support clinical operations
-Experience in diagnostic trials a plus
-Strong communication skills, both written and verbal
-Ability to laugh at yourself

To all recruitment agencies: Scipher Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, or Scipher Medicine employees. Scipher Medicine is not responsible for any fees related to unsolicited resumes.

Scipher Medicine 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.  Scipher will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.  

IF INTERESTED IN EXPLORING THIS OPPORTUNITY PLEASE EMAIL YOUR RESUME TO CAREERS@SCIPHERMEDICINE.COM