GLOBAL CLINICAL STUDIES MANAGER
Company: csci consulting, inc
Posted on: April 8, 2021
Clinical Operations Emeryville, CA Cambridge, MA Description
Position Summary: The primary role of the Global Clinical Studies
Manager (GCSM) is to manage and execute one or more assigned
clinical studies according to the objectives established by the
project team and corporate goals. The GCSM will be responsible and
accountable for all clinical operations activities related to the
execution of the assigned clinical studies within the expected
- Critical document development and review: Provide clinical
operations input into clinical study protocol and informed consent
form development. Create clinical operations and clinical study
document templates for utilization by the study team, CRO and study
sites. Direct the development of eCRFs and other data management
documents in collaboration with the CRO. Facilitate/direct the
development of other study/project plans as required.
- Study management: Manage all aspects of clinical study
execution. Lead the study execution team meetings. Work with
cross-functional counterparts to ensure that operational activities
are executed/delivered according to the expected timelines and
budget. Identify, establish, and ensure that study operational
activities track to key study milestones agreed with the project
- Timeline and budget management: Manage study timelines and
budgets. Provide monthly budget forecasts and accruals to Finance.
Review vendor invoices for accuracy and to ensure adherence to
budget. Approve vendor invoices. Track and initiate investigator
grant payments. Assist/support the development of clinical study
budgets as required.
- Vendor management: Function as the primary day-to-day contact
for assigned study vendors, including clinical CRO. Enable timely
study setup, site activation, patient recruitment, data entry and
query resolution, and issue resolution. Track and manage out of
- Oversight of site selection and management: Develop site
training materials and manuals. Ensure selection of qualified
investigators and sites. Facilitate review and negotiation of
clinical site agreements. Negotiate site study budgets. Ensure
execution of site contracts in line with planned timelines.
Proactively identify and remediate study issues.
- Site management: Function as the primary study contact for
clinical sites for studies or study activities managed internally
(eg., site startup). Enable timely completion of milestones (eg.,
site activation, data cleaning, etc.) to support corporate
objectives. Perform site visits (PSV, SIV, IMV, COV), as required,
to ensure adherence to study requirements.
- Routine study tracking: Track key study activities (eg.,
country startup, site activation, patient recruitment, patient
status, data collection, data review, etc.) and maintain study
metrics for routine reporting to the internal project team and
management. Develop study-specific tools to ensure timeliness,
standardization and control of quality data.
- Routine study communication: Provide relevant clinical study
operations updates to the internal project team and management,
including any variances to the timeline or budget. Proactively
identify solutions for issues that arise in study execution.
- Trial master file oversight: Establish and maintain TMFs in
line with departmental SOP.
- Contribute to departmental organization, including review/input
into departmental SOPs, harmonization of processes across studies,
and mentorship of junior team members.Minimum Education/Experience
- Bachelor's degree (or equivalent), preferably in scientific
discipline or a health- related
- 7 years relevant industry experience, with at least 5 years in
a clinical operations role (supporting or managing clinical trials)
at a sponsor
- Demonstrated proficiency in implementing, monitoring and
managing clinical studies, from study startup to study
- Thorough knowledge of ICH/GCP guidelines and FDA
- Previous experience with global oncology or immunotherapy
clinical studies preferred.Other Qualifications
- Able to work effectively and collaboratively in a fast-paced,
small start-up company environment.
- Must be self-motivated, highly organized, detail-oriented and
able to multi-task while delivering high quality
- Excellent interpersonal skills, including the ability to
influence and to work effectively cross-culturally and
- Strategic agility, strong critical and logical thinking with
ability to analyze
- Strong ability to prioritize and work in an evolving
- Excellent presentation and written/verbal communication
- Excellent computer proficiency (MS Word, Excel,
- Approximately 30% travel may be required. You have been
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Keywords: csci consulting, inc, Cambridge , GLOBAL CLINICAL STUDIES MANAGER, Executive , Cambridge, Massachusetts
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