Clinical Project Manager
Company: Technical Resources International
Posted on: January 13, 2022
Provide operational oversight of, and expertise to,
cross-functional project teams, that will include task/functional
managers who oversee the day-to-day operation for other functional
Plan and manage day-to-day operational aspects of one or more
assigned programs/projects,, including the following, as required:
planning/timelines, budgeting, resourcing, and vendor
management/interfacing. Identify and proactively work to remove
obstacles, mitigate risks, and escalates issues; both internally
and to the client [Contracting Officer's Representative (COR), or
designee(s)], as needed.
Interface with clients and program/project staff; ensure provision
of meeting agendas and summary documentation, as well as detailed
information required for internal and client meetings. Prepare
and/or review sections for monthly, quarterly, and annual reports;
may present at internal and/or scientific meetings.
Ensure documentation of processes and workflows are being followed
and occurring within projected timelines and determine course of
action to prevent and remediate delays. Identify gaps and propose
solutions to improve efficiency and quality of deliverables.
Carry out numerous and varied activities associated with the
conduct and successful performance of clinical trials/studies with
demonstrated expertise and ability to navigate in at least one SaaS
or project/contract-specific tool or system in support of the
following: patient recruitment; data management, collection and
processing of adverse events reports; tracking and reporting of
site monitoring/management activities, and/or regulatory document
collection (e.g., EDC, CTMS, or eTMF systems).
Represent eTMF and/or other clinical-trial related operations at
study team meetings, participate in collaborative efforts and play
an important cross-functional role, e.g., in eTMF document
retrieval and management. Perform a risk-based review of activities
being performed internally and by external vendors.
Perform duties within established SOPs and in accordance with Good
Clinical Practice (GCP). Ensure project quality and compliance with
FDA regulations and ICH (R2) guideline, and with NIH policies or
other sponsor-specific requirements.
Maintain a high level of accuracy and attention to detail in a
fast-paced environment with shifting priorities. Perform risk-based
quality content reviews and monitor internal/external KPIs.
Provide oversight and mentorship to staff in the delivery of
quality work and performance metrics, as per task order and/or
project deliverables, expected to include line management
responsibility and staff hiring.
Support and comply with the company's Quality Management System
policies and procedures. Drives innovative project and company
performance improvement solutions, including corrective and
preventive (CAPA) actions, as needed.
Bachelor's Degree in life science or another health-related field
(Master's Degree a plus).
5+ years minimum experience in the pharmaceutical or biotechnology
industry including Contract Research Organization (CRO) or other
clinical trials environment; e.g., regulatory or clinical
operations (In-house CRA, study coordinator, regulatory
documentation manager, or CRA/site monitor) experience.
Extensive knowledge and application of FDA/EMA and other regulatory
requirements, i.e., GCPs/ICH (R2) guidelines to include domestic
and global regulatory requirements.
Broad multidisciplinary understanding of the pharmaceutical
clinical research and development processes with hands on
regulatory, clinical operations, or clinical trial
monitoring/management experience, e.g., clinical study design,
conduct, management, reporting, and/or product development life
Excellent leadership skills with demonstrated ability to take a
leadership role and drive quality progress for a diverse team with
Display excellent organizational skills and exhibit professionalism
Demonstrated project and client management skills.
Strong presentation, problem-solving, and conflict resolution
Seasoned oral and written communication skills.
Expertise in Microsoft Word, PowerPoint, and Excel is required, and
experience with Microsoft Project.
Background in Infectious Disease/HIV clinical trials and/or
Oncology preferred; prior work on a government contract, is a
Keywords: Technical Resources International, Bethesda , Clinical Project Manager, Executive , Bethesda, Maryland
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