Site and Monitoring Health Lead

2 months ago

Nagpur, India Parexel Full time

When our values align, there's no limit to what we can achieve.
 

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 Client

Key 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 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 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 outliers

Operational

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 requirements

Skills:

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 preferred

Knowledge 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) preferred

Travel:

40-60% travel required

EEO Disclaimer
Parexel 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 origin, disability or protected veteran status.

  • Clinical Research Site Lead

    4 weeks ago

    Nagpur, Maharashtra, India Parexel Full time

    Job Summary:Parexel is seeking a Clinical Research Site Lead to join our team in the Northeast US or Florida. As a Site and Monitoring Health Lead, you will be responsible for ensuring the quality of clinical trial execution at investigator sites and overseeing the effectiveness of CRO monitoring.Key Responsibilities:Implement various types of oversight...

  • Site Supervisor

    6 months ago

    Nagpur, India PAC Full time

    **JOB DESCRIPTION: - ** - Ensure implementation of all appropriate health and safety standards - Complete site inspections and audits - Manage and direct all site activities - Maintain quality control and safety regulations - Control and supervise site activities - Manage and supervise the site workforce - Gain and maintain site access to public utilities -...

  • Site Supervisor

    5 months ago

    Nagpur, India larco india pvt ltd Full time

    Site Supervisor **Location**:Nagpur **Position**:6 **Salary**:20,000 - 35000 per Month **If You Want a Job Then Call Us Directly on : 9022442298** As a Site Supervisor, you will be responsible for overseeing and coordinating daily construction activities at project sites. Your role involves ensuring that work is carried out safely, efficiently, and in...

  • Site Supervisor

    2 weeks ago

    Nagpur, Maharashtra, India Leostar Solutions Full time

    Job OverviewWe are seeking a skilled Site Supervisor to oversee the operations at our construction sites. As a Site Supervisor, you will be responsible for coordinating and managing day-to-day activities, ensuring adherence to safety protocols, and ensuring timely completion of projects. This is a full-time position based in Nagpur, Maharashtra, India.Key...

  • Site Supervisor

    5 months ago

    Nagpur, Maharashtra, India Sandeep Dwellers Pvt. Ltd Full time

    Site supervisors oversee personnel working on construction projects. They ensure everyone adheres to workplace health and safety standards and that teams complete projects on schedule. If pursuing this career interests you, learning about the skills and qualities employers look for when recruiting can be beneficial. In this article, we explain what's...

  • Civil Site Supervisor

    6 months ago

    Nagpur, India Sath Outsourcing Service pvt. Ltd. Full time

    PROFILE - CIVIL SITE ENGINEER EDUCATION - CIVIL ENGINEER (PEB PREFERED) EXPERIENCE - 1 TO 2 (YEAR CIVIL SITE WOK) SALARY - 15000 TO 20000K LOCATION - SADAR, NAGPUR **Job Types**: Full-time, Regular / Permanent **Salary**: ₹15,000.00 - ₹20,000.00 per month **Benefits**: - Cell phone reimbursement - Health insurance - Provident Fund Schedule: -...

  • Civil Site Engg

    6 months ago

    Nagpur, India iconic consultants Full time

    CIVIL ENGG for site exp min 3yr salary 20000 to 25000 Location Nagpur interested share me resume on 9730139910 and call on 7558536446 **Job Types**: Full-time, Regular / Permanent **Salary**: ₹15,000.00 - ₹25,000.00 per month **Benefits**: - Health insurance - Provident Fund Schedule: - Day shift Supplemental pay types: - Commission pay -...

  • Site Supervisor

    3 weeks ago

    Nagpur, India Leostar Solutions Full time

    Company OverviewLeostar Solutions is a Nagpur-based Talent Acquisition Firm servicing PAN India. With multiple regional footprints/offices, we are a team of high-energy, experienced, and expertise professionals devoted to delivering high volume with uncompromised quality within timelines. Our workplace is characterized by ethics, integrity, and harmony, with...

  • WHS Officer

    4 weeks ago

    Nagpur, Maharashtra, India ASSPL - Maharashtra Full time

    Safety is our top priority at ASSPL - Maharashtra. We are seeking a dedicated WHS Officer to partner with our site operations team in a Fulfillment Center to execute company safety policies and ensure compliance to all applicable local and regional regulations.**Key Responsibilities:*** Lead continuous improvement initiatives to reduce conditional and...

  • Site Supervisor

    5 months ago

    Nagpur, Maharashtra, India Techmark Corporation Full time

    Role Description This is a full-time on-site role for a Civil Site Engineer. The Civil Site Engineer will be responsible for tasks such as on-site project management, communication with stakeholders, quality control, and implementing structural engineering principles. Qualifications: Civil engineering Ability to effectively manage on-site projects...

  • Construction Site Manager

    3 weeks ago

    Nagpur, Maharashtra, India Leostar Solutions Full time

    **Company Overview**At Leostar Solutions, we pride ourselves on being a high-energy talent acquisition firm with a strong presence across India. Our team of experienced professionals is dedicated to delivering high-quality results within tight timelines, guided by a culture of ethics, integrity, and harmony.**Job Overview**We are seeking a skilled and...

  • Site Supervisor

    2 months ago

    Nagpur, Maharashtra, India Sangita Sales Pvt Ltd Full time

    *Screen Survelliance *Monitoring of site activity *Preparing excel report *Taking follow up from site Pay: ₹12,000.00 - ₹15,000.00 per month Schedule: - Day shift - Night shift - Rotational shift Supplemental Pay: - Overtime pay - Yearly bonus Work Location: Remote

  • Site Supervisor

    6 months ago

    Nagpur, India DFG Services Full time

    DFG is a facility management service with experts in residential, commercial, and hospital facility management. With our 5-star-trained staff and efficient workforce, we provide the best housekeeping services in Nagpur. We have an excellent client base in Nagpur, with prominent support services catering to efficient management services. **We are looking for...

  • Mechanical Site Engineer

    3 weeks ago

    Nagpur, Maharashtra, India ADVANTAGESAI PROJECTS PVT. LTD Full time

    Company OverviewADVANTAGESAI PROJECTS PVT. LTD. is a leading firm in the fire protection industry, offering consultancy, sales, services, AMC, and training. As an authorized license holder of Maharashtra Fire Services, the company provides comprehensive fire detection, alarm, and protection systems across various cities in India.Job OverviewWe are seeking a...

  • Site Supervisor

    6 months ago

    Nagpur, India Blufoyer Full time

    Are you a dynamic and skilled professional looking to play a pivotal role in shaping architectural marvels and crafting stunning interiors? We're seeking an experienced **Site Supervisor** with a passion for both civil construction and home interior projects to join our dedicated team! **About Us**: Blufoyer is a place that brings together the best of...

  • Site Executive

    5 months ago

    Nagpur, Maharashtra, India Paradigm Consultancy Full time

    WE ARE HIRING Designation: - Site Executive : Real Estate Location: - Kothrud Pune Maharashtra Salary: - 18,000 To 22,000 Per Month Education: - Bachelor's degree in Civil Engineering or related field (preferred). Experience: - 1 -2 Years of Previous experience in a construction-related role is advantageous. **Responsibilities**: - Assist in...

  • Digital Marketing Executive

    5 months ago

    Nagpur, India The Lead Market Full time

    **Job description**: **Experience**: - 1-3 yrs - Conducting on-page and off-page analysis of competitor websites. - Creating high-quality content for backlinks. - Keyword research and optimization of content. - Excellent command on Google Analytics and Google Search Console and other SEO tools. - Good Knowledge on Google Ads. - Responsible for completing...

  • Data Miner

    5 months ago

    Nagpur, India The Lead Markets Full time

    **Job description** **Responsibilities and Duties** 3. Need to extract data from different sources like LinkedIn, zoom info, and other directories. **Key Skills** Basic Excel and Knowledge of LinkedIn. **Required Experience and Qualifications** Any Fresher Graduate/Post-Graduate. Graduation is MUST **Benefits** 1. On the Job Training will be given 2....

  • Jr. Digital Marketing Executive

    5 months ago

    Nagpur, India The Lead Markets Full time

    **Job Title**:Digital Marketing Executive **Location** : Nagpur **Experience **:1-3 yrs **Job description**: - Conducting on-page and off-page analysis of competitor websites. - Creating high-quality content for backlinks. - Keyword research and optimization of content. - Excellent command on Google Analytics and Google Search Console and other SEO...

  • Jr. Digital Marketing Executive

    5 months ago

    Nagpur, India The Lead Markets Full time

    **Job Title**:Digital Marketing Executive **Location** : Nagpur **Experience **:1-3 yrs **Job description**: - Conducting on-page and off-page analysis of competitor websites. - Creating high-quality content for backlinks. - Keyword research and optimization of content. - Excellent command on Google Analytics and Google Search Console and other SEO...