|Director of Clinical Operations
Sr. Director, Global Clinical Research Operations
DATE AVAILABLE ASAP
LOCATION Corporate Office in Lexington, Massachusetts
This role will be a key contributor to the company’s clinical development and primarily
responsible for the hands-on management and monitoring of early and late-stage
clinical studies in ultra rare disease indications. This position reports to the Senior
Director of Global Clinical Research Operations and will work closely with Program
Management and Medical and Commercial Operations in the creation and
management of the clinical development plans for rare disease programs and
ultimately, driving the planning activities to ensure successful execution and
completion of the clinical trial(s).
Leads the clinical trials implementation and has oversight of clinical trial CROs and
clinical laboratory vendors.
Drives clinical sub-team meetings and collaborates with Clinical Research and Medical
Operations to complete the following:
o Identification and management of Clinical Research Organization(s) and
other contractors as needed.
o Conducts protocol feasibility analysis, country assessment, site identification,
and patient recruitment planning.
o Identify investigators and provide assistance to facilitate timely selection of
investigators and sites
o Recruitment of patients and manage logistics for getting patients to sites for
clinical trials globally
o Implement site selection, site monitoring and recruitment plans
o Preparation and review of the protocol, CRFs, and informed consent forms.
o Prepare the coordinators manual, pharmacy manual and other
documentation required for the conduct of the global clinical trial(s)
o Collect and review essential documents for study start-up
o Ensure documents remain current during the course of the trial
o Maintain internal trial master file to ensure inspection readiness
o Interact with investigators to obtain necessary documentation and
information before, during and after the study. Ensure accurate inventory of
central, investigator site and core files on an ongoing basis to ensure that the
files are complete and can be used as a source of reference.
o Ensure that the site personnel have a good understanding of the protocol
and provide CRA training
o Maintain project tracking system on an ongoing basis to ensure that progress
regarding the sites can be tracked.
o Assist with the preparation and presentation at investigator meetings as
required to ensure that the clinical and investigational site staff team is well
informed about the study and related procedures.
o Prepare and manage detailed project plan in MS Project and clinical study
o Establish and ensure consistent use of clinical project planning processes.
o Interfaces with Program Management, Medical Operations and Commercial
to develop integrated clinical and commercial plans.
o Represents Clinical Research in presentations to Senior Management
o Provides clinical input into the preparation of clinical portions of project INDs
State or Province