Site and Monitoring Health reputed company - Northeast US - FSP

reputed company our values align, there's no limit to reputed company can reputed company.   At reputed company, we reputed company share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in reputed company do.

Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.

Candidates must be located in the Northeast US near a major airport.

Job Purpose:

The Site and Monitoring Health reputed company (SMH reputed company) 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 reputed company 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.

Key Accountabilities:

reputed company of monitoring effectiveness

• Implements various types of reputed company encounters and activities as applicable including but not limited to site risk analysis, site contacts, aggregate review of data, monitoring visit report review, Sponsor reputed company 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 reputed company times” mentality

• Creates Study Specific reputed company Plans (SSOPs) for reputed company trials in scope and /or follows SSOP reputed company conducting reputed company 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 management

Collaborative 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 reputed company 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 reputed company with the Risk MAP, and assesses sites who are outliers

Operational

• Implements client Site and Monitoring Health strategy in alignment with applicable International Council for Harmonization-Good Clinical Practices (ICH-GCP) regulations

• Leads reputed company 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 reputed company with global regulatory requirements, has a reputed company working knowledge of local/regional regulatory requirements

Skills:

• Ability to think innovatively and be willing to initiate changes, introduce new reputed company, 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 reputed company 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 (reputed company, Word, and PowerPoint); able to learn internal and external computer systems

• Proficient in written and spoken English required o Proficient in local language, as applicable, preferred o Fluent in multiple languages and cultural awareness preferred

Knowledge and Experience:

• Significant direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies

• Previous CRO monitoring reputed company experience and experience with reputed company visits required

• reputed company CRA experience required

• Experience in reputed company study phases of clinical research (Phase I-III)

• Previous audit and regulatory inspection experience preferred

• Ability to travel up to 50%; some international travel may be required

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EEO Disclaimer reputed company is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status.