Clinical Project Manager
Company: Beacon Hill Staffing Group - Pharma
Location: Quincy
Posted on: January 13, 2021
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Job Description:
We are looking for a Clinical Project Manager in our Clinical
Project Management group to be responsible for the independent
operational and financial management and oversight of multi-center
and/or external clinical site activities, ensuring compliance to
protocol, ICH \GCP, \SOP as well as regulatory and local
requirements This role will be home based anywhere in the United
States. Due to our international footprint, schedule flexibility is
important. This position will travel roughly 30% primarily in the
US, but could include Europe on an as needed basis. Essential
Responsibilities and Functions: Owns the client relationship with
Business Development and is responsible for client communication
ensuring high client satisfaction. Pro-active approach to providing
solution set for clients in a timely manner. Understand the scope
of the contract and any Master Services agreement (MSA) in place
for the client. Act as main line of communication between study
site personnel and the sponsor. Lead the kick off meetings with
client and internal project team, set and agree on milestones, and
work with different teams internally and with the client to deliver
the study on time and within budget, according to the relevant
SOPs. Lead the initiation, maintenance and close out activities of
multi-center and/or external site studies in accordance with the
protocol, GCP, and relevant SOPs Pro-actively communicate with the
client ensuring the client has all the information required on
project progress and status (risk analyses, contingency plans,
technical information, significant changes of any kind etc.);
provide pro-active decisions /solutions and how the project
objectives are being, or should be, achieved. Manage sites
efficiently Manage the completion and updates of timelines, tools
and project summaries as required Prepare project status reports
for management review. Coordinate with Regulatory Affairs and
manage the filing of the study required documents in the Trial
Master File (TMF) Independently troubleshoot and resolve any issues
that may arise. Support the evaluation of suitability of site
personnel and facility for initial and ongoing conduct of clinical
trial. Provide and support initial and ongoing training to site
personnel as needed. Review and training of proper oversight,
handling, and accountability of investigational product(s).
Collection and management of IRB submissions Verify the accuracy
and integrity of study data through collaboration with data
management Assist in the processing of SAE information received
from investigators including review, clarification and interactions
with monitors, sites and sponsor. Management of essential document
collection and maintenance, including initial and ongoing approval
of the study by a qualified ethics committee (IRB/EC). Oversight of
screening and recruitment activities, support site personnel with
strategies to ensure enrollment is on target. Maintain enrollment
logs regularly. Pro-active identification and mitigation or
resolution of issues affecting proper conduct of the trial,
including escalation to management and other team members as
appropriate to ensure proper resolution. Review monitoring
activities in a timely manner in accordance with SOP requirements.
Participate in the selection of study sites Manage pre-study, site
initiation, routine monitoring, and close out visits with team
members as needed. Participate in the review and development of
Protocol and CRF. Participate in development of operational plans
such as monitoring, data management and safety plans Coordinate and
oversee activities with external vendors Oversee the contents and
collection of ICH GCP essential documents, and the management of
the flow of required documents across sites Determine drug
requirements and management of study drug packing, shipping and
review of drug labels (as applicable) Manage study drug inventory
including ordering, shipping, retest/expiry, destruction/return and
tracking. Update and review of clinical trial management tracking
systems (CTMS) Run project team meetings and provide appropriate
updates and complete accurate and timely meeting minutes Review
audit reports and assist in resolution of cited issues. Engage in
process improvement activities and building of infrastructure
Knowledge/Skills/Education/Licenses: Bachelor's degree, preferably
in science, nursing, other biomedical discipline, or equivalent.
Masters or other advanced degree preferred. Minimum 5 years of
recent CRO experience Minimum of 3 + years of direct project
management experience in a CRO, Pharma, or Biotech. Minimum of
1+years of experience in project scheduling, managing resources and
budgets and coordinating team activities, as well as experience
with the full clinical development process through regulatory
submissions This position requires candidates to be
detailed-oriented, computer proficient in a Windows environment and
possess superior interpersonal and organizational skills Strong
public speaking skills Excellent oral and written communication
skills Working knowledge of ICH GCP and clinical research
regulations Excellent problem-solving and decision making skills
PMP is a plus
Keywords: Beacon Hill Staffing Group - Pharma, Quincy , Clinical Project Manager, Executive , Quincy, Massachusetts
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