We are not satisfied with the status quo. We interfere with the
genes responsible for disease. We break down barriers to progress,
partnering with the best and the brightest inside and outside our
company to do what is right for patients.
As innovators in the emerging field of RNAi, we seek fellow
revolutionaries – independent thinkers to join our growing team,
advance our robust pipeline of therapies and provide
ground-breaking medicines to those who need it most.
Our office locations in Cambridge, Massachusetts, and Lexington,
Massachusetts, as well as our facility in Boulder, Colorado,
provide proximity to world-class research, academic and healthcare
institutions as well as other life sciences leaders.
We offer competitive salaries and benefits packages and are
proud to be an equal opportunity employer.
Our mission We interfere with disease We use RNA interference,
or RNAi, to create medicines that silence the genes that cause
disease. Our goal is to provide life-changing therapies to people
living with rare diseases and common diseases that have a genetic
The Senior Data Manager will be responsible for oversight of
clinical data management (CDM) activities for assigned programs
and/or studies. The successful candidate will proactively oversee
CDM execution of CRO outsourced and/or FSP managed trials from
study startup through study closure in support of trial objectives
and corporate goals. This position reports to the Director of Data
Provide study and/or program-level oversight of clinical data
Collaborate with clinical study teams and vendors to meet
project deliverables, including data acquisition, quality checking
and reporting in compliance with GCP, SOPs and regulatory
Oversee the development of study-specific CDM documentation such
as eCRF specifications, eCRF completion guidelines, annotated CRFs,
edit check specifications, and data management plans – identifying
and mitigating risks to data quality and proper inclusion into the
Trial Master File (eTMF).
Oversee the activities of CRO DM functional counterparts to
ensure adherence to scope of work and service agreements, and to
ensure deliverables are met in accordance with study
milestones/timelines and with quality.
Perform thorough development testing of the eCRF prior to
deployment, inclusive of creating or overseeing vendor User
Acceptance Test (UAT) Plans, Test Scripts and execute testing as
Ensure completeness, accuracy and consistency of clinical data
across all assigned studies.
Participate in internal study team meetings as well as
teleconferences with outside vendors and study personnel.
Report query trends and data/query metrics to the study
Review data transfer specifications/agreements for consistency
with study and program needs.
Represent data management at Investigator Meetings and may
present EDC and Case Report Forms to investigators.
Assist in implementation of key performance and quality
Track and review key performance indicators on data entry,
source verification, and query status; perform quality control on
those metrics to ensure accuracy.
Participate in study document reviews, e.g. clinical study
protocols, statistical analysis plans, Mock Tables, Figures and
Listings (TFL) shells.
Review data listings prior to final database locks.
BS/BA in Life Science or related discipline.
3+ years of clinical data management experience in the
pharmaceutical/CRO industry. At least 1 year on the sponsor
3+ years of Electronic Data Capture (EDC) experience including
Global clinical trial and CRO management experience.
Strong working knowledge of FDA & ICH/GCP regulations and
Strong knowledge with CDISC (CDASH/SDTM), medical dictionary
coding standards, FDA and ICH guidelines, GCP, 21 CFR Part 11,
Clinical Data Management best practices.
Experience with SAS or SQL programming techniques with clinical
data management application a plus.
Demonstrated ability to work independently to manage complex
projects with multiple priorities in a fast paced, team-based
Experience with DIA TMF reference model pertaining to CDM
Ability to perform limited travel as needed.
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