Trial Vendor Manager - Masco Corporation
Durham, NC
About the Job
Job Purpose
This is a sponsor dedicated role! As a Vendor Lead you will be a Single Point of Contact (SPOC) for supplier services at a trial level and be the first point for issue escalation during study start up, acting as a conduit for clear communication and robust daily oversight.
Job Overview
Clinical Leads/Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Clinical Lead/Senior Clinical Lead is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies to meet contractual requirements and in accordance with (Standard Operating Procedures) SOPs, policies and practices. Clinical Leads/Senior Clinical Leads ensure clinical delivery to customers by leading clinical teams and partnering with Project Leaders and other functional teams to ensure projects meet delivery requirements at all times.
Essential Functions
+ Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
+ Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
+ Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle.
+ Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
+ Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
+ Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
+ Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
+ Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
+ Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
+ Conduct regular team meetings and communicate appropriately to achieve objectives.
+ Support professional development by providing feedback to clinical team line managers on performance relative to project tasks to support professional development.
+ Adopt corporate initiatives and changes and serve as a change advocate when necessary.
+ May contribute to the development of the clinical delivery strategy for business proposals. Participate in bid defense preparations and meetings. Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership.
+ May mentor and coach new peers as they assimilate into this role.
+ May attend site visits as applicable in support of project delivery.
+ Other responsibilities include: Close interaction and collaboration with study team lead and study team members during study lifetime, Responsible for driving timelines and deliverable management of all external activities from identification of supplier needs to global set up of suppliers. Responsible for directing the vendor on the specific study requirements for system set up and leading the design, build, testing and validation of the system (UAT). Collaborate with the Study Lead, External Relationship Lead, Procurement, and the Quality Assurance teams (QA) to assure the set up and delivery of ECOA supplier providers
Qualifications
+ Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required
+ Requires 5-7 years clinical research/monitoring experience or equivalent combination of education, training and experience.
+ Previous experience in: vendor management, system design, demand & contracting process.
+ Expertise with one of these vendors are required: eCOA, IRT, Central lab
+ Requires consolidated knowledge of Project management practices and terminology.
+ Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
+ Requires broad protocol knowledge and therapeutic knowledge.
+ Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.
+ Requires understanding of project finances.
+ Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.;
+ Communication - Strong written and verbal communication skills including good command of English language.
+ Problem solving - Problem solving skills.
+ Organization - Planning, time management and prioritization skills. Prioritization - Ability to handle conflicting priorities.
+ Quality - Attention to detail and accuracy in work.
+ Results-oriented approach to work delivery and output.
+ Leadership - Good influencing and negotiation skills. Good judgment and decision-making skills. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
+ IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint;
+ Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients.
+ Cross-collaboration - Ability to work across geographies displaying a high awareness and understanding of cultural differences.
+ IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership)
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
The potential base pay range for this role, when annualized, is $112,000.00 - $186,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
This is a sponsor dedicated role! As a Vendor Lead you will be a Single Point of Contact (SPOC) for supplier services at a trial level and be the first point for issue escalation during study start up, acting as a conduit for clear communication and robust daily oversight.
Job Overview
Clinical Leads/Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Clinical Lead/Senior Clinical Lead is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies to meet contractual requirements and in accordance with (Standard Operating Procedures) SOPs, policies and practices. Clinical Leads/Senior Clinical Leads ensure clinical delivery to customers by leading clinical teams and partnering with Project Leaders and other functional teams to ensure projects meet delivery requirements at all times.
Essential Functions
+ Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
+ Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
+ Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle.
+ Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
+ Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
+ Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
+ Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
+ Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
+ Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
+ Conduct regular team meetings and communicate appropriately to achieve objectives.
+ Support professional development by providing feedback to clinical team line managers on performance relative to project tasks to support professional development.
+ Adopt corporate initiatives and changes and serve as a change advocate when necessary.
+ May contribute to the development of the clinical delivery strategy for business proposals. Participate in bid defense preparations and meetings. Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership.
+ May mentor and coach new peers as they assimilate into this role.
+ May attend site visits as applicable in support of project delivery.
+ Other responsibilities include: Close interaction and collaboration with study team lead and study team members during study lifetime, Responsible for driving timelines and deliverable management of all external activities from identification of supplier needs to global set up of suppliers. Responsible for directing the vendor on the specific study requirements for system set up and leading the design, build, testing and validation of the system (UAT). Collaborate with the Study Lead, External Relationship Lead, Procurement, and the Quality Assurance teams (QA) to assure the set up and delivery of ECOA supplier providers
Qualifications
+ Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required
+ Requires 5-7 years clinical research/monitoring experience or equivalent combination of education, training and experience.
+ Previous experience in: vendor management, system design, demand & contracting process.
+ Expertise with one of these vendors are required: eCOA, IRT, Central lab
+ Requires consolidated knowledge of Project management practices and terminology.
+ Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
+ Requires broad protocol knowledge and therapeutic knowledge.
+ Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.
+ Requires understanding of project finances.
+ Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.;
+ Communication - Strong written and verbal communication skills including good command of English language.
+ Problem solving - Problem solving skills.
+ Organization - Planning, time management and prioritization skills. Prioritization - Ability to handle conflicting priorities.
+ Quality - Attention to detail and accuracy in work.
+ Results-oriented approach to work delivery and output.
+ Leadership - Good influencing and negotiation skills. Good judgment and decision-making skills. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
+ IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint;
+ Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients.
+ Cross-collaboration - Ability to work across geographies displaying a high awareness and understanding of cultural differences.
+ IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership)
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
The potential base pay range for this role, when annualized, is $112,000.00 - $186,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Source : Masco Corporation