Site and Monitoring Health Lead - Northeast or Florida - FSP
Company: Parexel International Corporation
Location: Billerica
Posted on: October 23, 2024
Job Description:
Parexel is seeking a Site and Monitoring Health Lead in the
Northeast US or in Florida.Position Purpose:The Site and Monitoring
Health Lead (SMH Lead) will apply knowledge of regulations and GCPs
as well as experience in monitoring to safeguard the quality of
clinical trial execution at investigator sites and ensure the
client's oversight of CRO monitoring effectiveness. This is a
site-facing position that reports to the FSP Manager, with work
directed by the client Associate Director (or above), Site and
Monitoring Health Team.Organizational Relationships:
- Reports to Functional Service Provider (FSP) Line Management
with day-to-day direction from the ClientKey Accountabilities:
Oversight of monitoring effectiveness
- Implements various types of oversight encounters and activities
as applicable including but not limited to site risk analysis, site
contacts, aggregate review of data, monitoring visit report review,
Sponsor Oversight
- Visits, system/data spot checks, and periodic summaries; ensure
timely documentation of these activities is completed and file
- Completes Sponsor Oversite Visit reports consistently on time
and with good quality
- Utilizes a risk-based approach to review critical to quality
items at the site level and study level, exhibiting an "inspection
ready at all times" mentality
- Creates Study Specific Oversight Plans (SSOPs) for aligned
trials in scope and /or follows SSOP when conducting oversight
activities
- Troubleshoots and uses alternative and innovative approaches to
solve problems impacting clinical site delivery and quality
- Utilizes root cause analysis to assess identified issues and
provide suggested actions to Study Management/Clinical Research
Organization(CRO) to mitigate risk
- Supports inspection preparation and managementCollaborative
Relationships
- Works both independently and collaboratively with
cross-functional teams
- Builds relationships with investigators and site staff in
region; acts as a resource for identifying potential sites for new
studies
- Supports investigator sites less experienced in research;
assists in assuring sites are engaged in the study and have what
they need to recruit participants successfully
- Works closely with Clinical Risk and Analytics staff to
understand the risk management plan (Risk MAP) for assigned
studies, ensures the SSOP is aligned with the Risk MAP, and
assesses sites who are outliersOperational
- Implements client Site and Monitoring Health strategy in
alignment with applicable International Council for
Harmonization-Good Clinical Practices(ICH-GCP) regulations
- Leads oversight and trend meetings with the study team and/or
Clinical
- Research Organization (CRO) to discuss risks, issues, and
trends identified by the SMH team for the trial
- Remains current with global regulatory requirements, has a
current working knowledge of local/regional regulatory
requirementsSkills:
- Ability to think innovatively and be willing to initiate
changes, introduce new ideas, and creatively problem-solve
- Ability to build and maintain relationships with key
investigators and sites (e.g. key networks, key trial sites and
investigators, key opinion leaders and their stie staff)
- Ability to analyze complex situations and effectively
communicate issues along with potential recommendations to various
functional groups
- Demonstrates good judgment and decision-making experience
- Ability to travel approximately 50%; may include local,
regional, and international travel
- Demonstrates flexibility in schedule and willing to travel
frequently in assigned region
- Good organizational skills and ability to deal with competing
priorities
- Effective interpersonal verbal, written and presentation
communication skills
- Proficient with MS Office Suite (Excel, Word, and PowerPoint);
able to learn internal and external computer systems
- Proficient in written and spoken English required
- Proficient in local language, as applicable, preferred
- Fluent in multiple languages and cultural awareness
preferredKnowledge and Experience:
- Significant direct monitoring experience gained with a CRO or
pharmaceutical company working on multinational clinical
studies
- Lead CRA/management experience preferred
- Experience in all study phases of clinical research (Phase
I-III) and experience in both prevalent and rare medical conditions
preferred
- Previous audit and regulatory inspection experience preferred
Education:
- Bachelor's Degree required
- Clinical or advance degree (Registered Nurse (RN), Masters in
Public Health (MPH), Masters of Science (MS), Masters of Arts (MA),
Masters in Business Administration (MBA), Doctorate in Pharmacy
(Pharm D) preferredTravel:
- 40-60% travel required#LI-REMOTE
Keywords: Parexel International Corporation, Lowell , Site and Monitoring Health Lead - Northeast or Florida - FSP, Healthcare , Billerica, Massachusetts
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