Lead Study Monitor USA

2 weeks ago

Hartford, United States Clingroup Full time

Lead Study Monitor - United States of America

Clinglobal is part of a group of Animal Health Contract Research Organisations servicing the global animal health industry.

We're actively seeking a North American based senior Study Monitor to join our expanding Field Clinical Trials team

This role provides the flexibility to work remotely, with occasional office visits required to Waverley, New York.

Primary Job Purpose

Lead the Monitor team across all participating countries in a specific study and actively engage in Monitoring activities. Collaborate with Study Monitors and support the Clinical Trial Project Manager to ensure studies adhere to scientific design and timelines outlined in the study Protocol, Standard Operating Procedures (SOPs), Policies, regulatory guidelines, and quality standards (e.g., VICH GL9 GCP).

Serve as the primary contact for Study Monitors and their designated clinical study sites/Investigators, providing consistent updates to the Clinical Project Manager .

Job Specific Duties and Responsibilities

Coordinate and lead a team of study Monitors working on a particular study.

Monitor study sites, including activities associated with study initiation, execution, close-out, and submission, and verify the data collected.

Train sites on study protocols and GCP.

Compile Monitor reports to report on the progress of the study and obtain corrective actions as necessary.

Assist with site selection and evaluation.

Serve as point of contact between the Clinglobal group and study sites/Investigators.

Mentor and train fellow team members on study Monitor management.

Assist the Clinical Trial Project Manager with study activities, including but not limited to reviewing draft protocols, overseeing sites’ budgets and invoices, and maintenance of monitoring tools.

Serve as point of contact for new clinical study sites/Investigators.

Provide oversight of study master files (electronic and paper) and prepare the study files for archiving/submission.

Liaise and coordinate with different departments, partner companies, and external partners to support the Clinical Trial Project Manager in ensuring that necessary resources are available to perform the required function at the planned time to achieve the project outcomes.

Ensure study sites/Investigators fulfil their responsibilities to meet the agreed timelines, quality, and cost.

Proactively identify risks that might jeopardize projects, e.g., technical feasibility, sites’ suitability, timely execution, budget constraints, etc.

Develop and maintain project management tools, including but not limited to Gantt charts, project budgets, forecasts, etc.

Promote the organization’s capabilities and values internally and externally.

Leading global study-level documentation and required tool and systems set-up.

Author and review monitoring-related controlled documents, where applicable.

Qualification, Training and Experience Requirements

Bachelor's degree in a relevant Life Sciences field.

Minimum of five years' experience in Study Monitoring within Animal Health or Human Pharma sectors.

Industry knowledge, including familiarity with FDA/CVM, USDA/CVB, EMA, VICH Guidelines, Clinical Field Trials, and Data quality requirements.

Strong technical writing and oral presentation skills in English.

Competence in Electronic Data Capture Systems.

Important Note to Applicants

This is a

remote position

with potential for regular travel.

Please be aware that Internet Explorer is not compatible with BambooHire.

The Company complies with local and international data protection and privacy legislation. This includes transparency in the processing of personal information processed about job applicants during the recruitment process. By applying for this position, applicants agree to the processing of their personal data in accordance with our recruitment procedure and Privacy Notice available from our website.

As part of the hiring process, candidates need to willingly take part in personality and behaviour assessments to determine a good fit for the job role. These assessments assist with evaluation of candidates in a fair and thorough manner. All information gathered are kept private and only used to assess suitability for the job role.

The Company may perform criminal and/or other relevant checks (as is relevant to the position) on all applicants applying for this position.

#J-18808-Ljbffr

  • Business Owner with Relocation to the USA

    6 days ago

    Hartford, United States Work Visa Usa Jobs (move2usajobs.com Llc) Full time

    Work Visa USA Jobs (move2usajobs.com LLC) | Full time Business Owner with Relocation to the USA Hartford, United States | Posted on 05/05/2024 Business Owner - Relocation to the USAWe are offering an unparalleled opportunity for ambitious entrepreneurs and business owners to relocate their businesses or start a new venture in the United States. This program...

  • Marketing Manager with Relocation to the USA

    1 week ago

    Hartford, United States Work Visa USA Jobs (move2usajobs.com LLC) Full time

    Work Visa USA Jobs (move2usajobs.com LLC) | Full time Marketing Manager with Relocation to the USA Hartford, United States | Posted on 05/05/2024 We're offering a remarkable opportunity for Marketing Managers to apply their strategic marketing skills and creativity in the United States. This role is designed for individuals who are passionate about building...

  • Information Security Specialist

    2 weeks ago

    Hartford, United States Work Visa USA Jobs (move2usajobs.com LLC) Full time

    Job DescriptionAn excellent opportunity awaits Information Security Specialists who are ready to take their careers to the next level in the United States. This role is designed for cybersecurity professionals who are passionate about protecting digital assets, ensuring data privacy, and mitigating cyber threats in a dynamic and challenging environment....

  • 2306m - Principal Engineer, Transmission Planning - Special Studies

    1 week ago

    Hartford, United States MRINetwork Jobs Full time

    Job Description Job Description Provides technical leadership, conducts complex transmission system planning studies, recognized as having technical expertise, elicits ideas for the solution of unique and/or complex engineering problems, and is accountable for major technical recommendations. Mentors other engineers or groups of engineers and their projects...

  • 2306m - Principal Engineer, Transmission Planning - Special Studies

    3 weeks ago

    Hartford, United States MRINetwork Jobs Full time

    Job DescriptionJob DescriptionProvides technical leadership, conducts complex transmission system planning studies, recognized as having technical expertise, elicits ideas for the solution of unique and/or complex engineering problems, and is accountable for major technical recommendations. Mentors other engineers or groups of engineers and their projects as...

  • Snowflake Data Lead

    2 weeks ago

    Hartford, United States ClifyX Full time

    1245972 Snowflake Data Lead New Hartford ( New York Currently Remote but work from office client's offices open up Salary : $150 K No H1B transfer case Snowflake Data Lead 10 + Years Experience Location: USA Technical Skills: (Primary) Database Technologies: Snowflake, SQL, Relational Databases Exposure to Data warehousing and various ingestion patterns...

  • Snowflake Data Lead

    3 days ago

    Hartford, United States ClifyX Full time

    1245972 Snowflake Data Lead New Hartford ( New York Currently Remote but work from office client's offices open up Salary : $150 K No H1B transfer case Snowflake Data Lead 10 + Years Experience Location: USA Technical Skills: (Primary) Database Technologies: Snowflake, SQL, Relational Databases Exposure to Data warehousing and various ingestion patterns...

  • Business Analyst Lead

    2 weeks ago

    Hartford, United States AXA XL Ltd Full time

    Business Analyst Lead Hartford, CT I Stamford, CT I New York, NY I USAThe Business Analyst Lead is accountable for the Analysis practice within the Digital Factory.  S/he will be responsible for staffing and allocations, overall performance of analysts across projects, maintenance and production support, and the implementation of analysis best practices,...

  • Business Analyst Lead

    3 days ago

    Hartford, United States AXA XL Ltd Full time

    Business Analyst Lead Hartford, CT I Stamford, CT I New York, NY I USAThe Business Analyst Lead is accountable for the Analysis practice within the Digital Factory.  S/he will be responsible for staffing and allocations, overall performance of analysts across projects, maintenance and production support, and the implementation of analysis best practices,...

  • SRE Lead

    3 weeks ago

    Hartford, United States Tata Consultancy Services Full time

    Job Title SRE Lead Relevant Experience(in yrs) 5+ Work Location(State, City and Zip) Hartford, Connecticut Technical/Functional Skills Hands On Experience in Application Production support, debugging, triaging till resolution experience of applications. Hands on extensive automation experience in ansible Experience in Incident, Change and AWS...

  • Sales Team Lead

    4 weeks ago

    Hartford, United States Onward Search Full time

    As a Sales Team Lead for our client, a leading real estate marketplace, you will play a pivotal role in driving revenue through innovative digital advertising and marketing solutions for the residential real estate industry. We are seeking a dynamic leader with a passion for coaching and mentorship to shape and elevate our sales team.   This role offers a...

  • SRE Lead

    3 weeks ago

    Hartford, United States Tata Consultancy Services Full time

    Job Title SRE Lead Relevant Experience (in yrs) 5+ Work Location (State, City and Zip) Hartford, Connecticut Technical/Functional Skills HandsOn Experience in Application Production support, debugging, triaging tillresolution experience of applications. Handson extensive automation experience in ansible Experiencein Incident, Change and AWS Infrastructure...

  • Clinical Trial Manager

    3 weeks ago

    Hartford, United States BioCT Innovation Commons Full time

    Overview Join a well-established and collaborative Clinical Operations team in a Clinical Trial Manager role with opportunity for career enrichment. As the operational leader of the study team, the Clinical Trial Manager (CTM) works closely with internal team members and vendors ensuring clinical trials are completed according to protocol, SOPs,...

  • Lead Data Exchanges MuleSoft Developer

    7 days ago

    Hartford, United States Resource Informatics Group Full time

    Position: Lead Data Exchanges MuleSoft Developer Location: Hartford, CT 06106, USA Duration: 12 Months Candidate must be a US Citizen or Permanent Resident Candidate must be able to come in the office 2 days every 2 weeks or 1 day per week. Note: Skills to be prioritized is Salesforce, APEX and APEX design patterns. The agency needs the service of a senior...

  • Business Development Manager

    7 days ago

    Hartford, United States Securitas Security Services USA, Inc. Full time

    Securitas Security Services USA, Inc. Position Title: Area Business Development Manager Location: Connecticut and Western Massachusetts Company Credentials: Securitas is a globally present and industry-leading security organization and a trusted provider of cost-effective, risk-mitigating, business-to-business solutions. Our mission is to help protect...

  • AWS Terraform Lead

    7 days ago

    Hartford, CT, United States Cedent Consulting Full time

    Title: AWS Terraform Lead @ Hartford, CT Terms of Hire: Full time Salary: $ Open K/ YR + Benefits. Job description:   Qualification: B S in Engineering in Computers or Relevant Diploma Degrees Responsibility: Business / Customer Understand and articulate complex problems related to the specific technology.Provide business development support by assisting...

  • Business Development Manager

    3 days ago

    Hartford, United States Securitas Security Services USA, Inc. Full time

    Securitas Security Services USA, Inc. Position Title: Area Business Development Manager Location: Connecticut and Western Massachusetts Company Credentials: Securitas is a globally present and industry-leading security organization and a trusted provider of cost-effective, risk-mitigating, business-to-business solutions. Our mission is to help protect our...

  • Underwriting Portfolio Risk Analyst Sr

    1 week ago

    Hartford, United States Peacefestival Full time

    Opportunities for Underwriting Portfolio Risk Analyst Sr in Hartford, CT Remote positions only Search completed. Found 0 matching records. Opportunities for Underwriting Portfolio Risk Analyst Sr in Hartford, CT Remote positions only Search completed. Found 0 matching records. Underwriting Consultant, Light Brokerage Berkley We take risk management...

  • Autonomous System Development Lead

    9 hours ago

    East Hartford, United States Raytheon Research Center Full time

    **Date Posted**: 2024-05-16 **Country**: United States of America **Location**: RC1: United Tech Research Center 411 Silver Lane, East Hartford, CT, 06108 USA **Position Role Type**: Hybrid - Job Description For more than 90 years the RTX Technology Research Center (RTRC) has operated as a multidisciplinary group of experts collaborating on groundbreaking...

  • Guidewire Performance Test Lead

    6 days ago

    Hartford, United States Avtech solutions Full time

    Position: Guidewire Performance Test Lead Location: Hartford, Connecticut / St. Paul, MN (Onsite) Contract Position Job Description Skills Required: Hands on Performance test experience of Guidewire cloud platform using LoadRunner, JMeter, Ready API, Dynatrace, Splunk & Data Dog Experience with Guidewire, Digital applications/portal...