Remote Clinical Trial Manager
Posted on: April 9, 2021
Description:The Clinical Trial Manager (CTM) provides trial
oversight of investigational sites, CROs and vendors (including
both U.S. and Ex-U.S. regions). This role also assures adherence to
GCP, regulations and applicable procedures, in addition to protocol
compliance and that of study related plans. The CTM will also be
responsible for monitoring all phases of clinical studies, as
needed. This position will also provide input, support and
maintenance of department clinical projects and infrastructure. The
CTM reports to the Director of Clinical
- Vendor (e.g., CRO, Biometrics, IRT, PK/Central Lab, eTMF,
Safety) oversight for adherence to budget, timelines and
organizational objectives and goals covering multiple regions.
- Contributes to ongoing department infrastructure development
efforts such as SOP development, implementation and/or innovation
of new processes for assigned studies within the department.
- Performs clinical study site management/monitoring activities
in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations,
Protocol, Site Monitoring Plan and associated documents for global
regions (e.g., EU, APAC, China).
- Develops strong vendor and site relationships and ensures
continuity of relationships through all phases of the trial.
- Obtains and maintains in-depth understanding of the study
protocol and related procedures in order to contribute strongly to
study team knowledge by sharing best practices, making
recommendations for continuous improvement and providing training
- Participates & provides input on study site selection
- Coordinates & manages various tasks in collaboration with other
sponsor roles to achieve site readiness, such as study materials
and approval for drug shipping/receipt according to procedure.
- Performs remote and on-site monitoring & oversight activities
using various tools to ensure:
- Data generated at sites is complete, accurate and unbiased
- Subjects' right, safety and well-being are protected
- May conduct site visits, including but not limited to, site
selection, site initiation, interim monitoring, close-out, CRA
oversight, and co-monitoring. Records in support of these
monitoring visits must be timely, clear, comprehensive and
- Performs timely review of monitoring reports and associated
deliverables demonstrating sponsor oversight.
- Collects, reviews, and monitors required regulatory/operational
documentation for study start-up, study maintenance and study
- Supports clinical document control activities and associated
study staff to ensure the content and management of the
electronic/paper Trial Master File (eTMF/TMF) is current and
- Perform periodic reviews of the eTMF/TMF to ensure adherence
with standards and compliance with the relevant regulations and
- Communicates with Investigators and site staff on issues
related to protocol conduct, recruitment, retention, protocol
deviations, regulatory documentation, site audits/inspections and
overall site performance.
- Identifies, assesses and resolves site performance, quality or
compliance problems and escalates per defined process as
appropriate in collaboration with clinical operations
- Contributes to CRA team knowledge by acting as process Subject
Matter Expert (SME), sharing best practices, making recommendations
for continuous improvement and providing training as
- Tracks and coordinates trial related material availability,
including clinical trial supplies and laboratory samples
- Works with vendors to revise scope of service agreements,
budgets, plans and detailed timelines, and ensure that performance
expectations are met.
- Supports financial management of the study which includes
review and approval of site and vendor invoices.
- Supports risk Management initiatives
- Supports audit/inspection activities as needed.
- Maintain clinical trial registry entry/updates, as
- Provides mentorship/guidance to junior team members or
cross-functional colleagues on study processes/study
- BA/BS in related scientific or healthcare field, a combination
of relevant education and applicable job experience may be
- 5 years of direct site management (monitoring) experience in a
Biopharmaceutical or Pharmaceutical company, with Phase 1 through 4
studies, both domestic and international.
- 3-5 years study oversight as an in-house CTM (e.g., CRO/vendor
- Experience in running a trial from start to finish; initiating
the trail that includes protocol writing, ICF generation, site
feasibility/start up training, contract and budget negotiation,
vendor management, CRF design, maintaining a trial and study close
- Travel up to 30% with overnight stays.
- Fluent in English (verbal and written) and excellent
communication skills, including the ability to understand and
present technical information effectively.
- Excellent understanding and working knowledge of clinical
research, phases of clinical studies, current ICH GCP & country
clinical research law & guidelines.
- Excellent understanding of Global, Country/Regional Clinical
Research Guidelines and ability to work within these
- Demonstrated ability to mentor/lead.
- Hands on knowledge of Good Documentation Practices.
- Performs independently and professionally when managing both
site/vendor oversight and monitoring responsibilities, and as
applied across multiple protocols, sites and therapeutic
- Strong IT skills (Use of MS office, use of various clinical IT
applications on computer, tablet and mobile devices) and ability to
adapt to new IT applications on various devices.
- Ability to understand and analyze data/metrics and act
- Possesses effective time management, organizational and
interpersonal skills, conflict management, problem-solving
- High sense of accountability/urgency. Ability to set priorities
and handle multiple tasks simultaneously in a changing
- Works effectively in a matrix cross-functional environment.
Ability to establish and maintain culturally sensitive working
- Works with high quality and compliance mindset. About
Aerotek:We know that a company's success starts with its employees.
We also know that an individual's success starts with the right
career opportunity. As a Best of Staffing Client and Talent leader,
Aerotek's people-focused approach yields competitive advantage for
our clients and rewarding careers for our contract employees. Since
1983, Aerotek has grown to become a leader in recruiting and
staffing services. With more than 250 non-franchised offices,
Aerotek's 8,000 internal employees serve more than 300,000 contract
employees and 18,000 clients every year. Aerotek is an Allegis
Group company, the global leader in talent solutions. Learn more at
Aerotek.com.The company is an equal opportunity employer and will
consider all applications without regards to race, sex, age, color,
religion, national origin, veteran status, disability, sexual
orientation, gender identity, genetic information or any
characteristic protected by law.
Keywords: Aerotek, Denver , Remote Clinical Trial Manager, Executive , Denver, Colorado
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