Syneos Health, Inc.
Overview
Updated: Yesterday. Location: CHN-Client. Job ID: 25101923. Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong. Job Responsibilities
Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level. Leads (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials. Provides support to SSUL to agree on country template contract and budget. Produces site-specific contracts from country template. Provides support in submissions for proposed contract and budget for sites. Supports negotiation of budget and contract with sites via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. Reviews contracts for completeness and accuracy, and ensures corrections are appropriately made and documented. Supports business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings. Collaborates with Contract Managers and team members on active project management of ongoing contract issues; follows up on all outstanding contract issues. Supports generation of amended contract and/or budget documents as necessary, prepares contract management documentation for projects, and streamlines contract/proposal or internal processes; initiates and introduces creative ideas and solutions. Works within forecasted country/site contracting timelines, ensures compliance, and tracks milestone progress in real time. Collaborates with internal and external legal, finance, and clinical operations departments, including explaining legal and budgetary issues. Facilitates execution of contracts by company signatories. Maintains contract templates and site-specific files and databases. Trains and mentors less experienced staff on SOPs and ensures quality of team outcomes. Maintains and updates training material for site contract team. Acts as a communication liaison between site contracts staff and internal/external customers. Provides functional guidance and keeps teams aware of contract statuses or pending issues. Prepares correspondence as necessary. Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion. Reviews and complies with SOPs and Work Instructions (WIs); keeps training records updated and ensures timesheet compliance. Qualifications
BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience. Advanced degree preferred. High level of contracts management experience. Experience in a contract research organization or pharmaceutical industry essential. Strong knowledge of the clinical development process and legal and contracting parameters. Strong computer skills in Microsoft Office Suite. Customer focused with ability to manage challenging priorities and remain flexible and adaptable in stressful situations. Excellent understanding of clinical trial processes across Phases II-IV and ICH GCP. Good understanding of clinical protocols and study specifications. Excellent understanding of clinical trial start-up processes. Project management experience in a fast-paced environment. Good vendor management skills. Excellent written/oral communication, presentation, documentation, interpersonal skills and strong team orientation. Strong organizational skills with proven ability to handle multiple projects. Quality-driven with strong negotiating and problem-solving skills. Ability to mentor, lead and motivate junior staff. Provide quality feedback and contribute to training and Quality Assurance plans within SSU and update SOPs/WIs. Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within the Site Start-Up/Site ID job family are responsible for managing and executing the site identification process in accordance with regulations, SOPs, and project requirements. This includes completing and negotiating site confidentiality agreements (CDAs) and site information forms (SIFs) with sites, maintaining, reviewing, and reporting on site performance metrics, serving as the primary point of contact for investigative sites, and tracking the completion of site identification for sites. The role describes impact and contribution for individual contributors with responsibility in a professional or technical discipline, including potential management of junior staff. The description also notes the typical profile of an established and productive individual contributor. Description Site Contract Specialist II Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level. Leads (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials. Provides support to SSUL to agree on country template contract and budget. Produces site-specific contracts from country template. Provides support in submissions for proposed contract and budget for site. Supports negotiation of budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. Reviews contracts for completeness and accuracy, and ensures corrections are appropriately made and documented. Supports business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings. Work with Contract Managers and team members on active project management of ongoing contract issues; follows up on all outstanding contract issues. Supports generation of amended contract and/or budget documents as necessary, prepares contract management documentation for projects, and streamlines contract/proposal or internal processes; initiates and introduces creative ideas and solutions. Works within forecasted country/site contracting timelines, ensures compliance, and tracks milestone progress in real time. Collaborates with internal and external legal, finance, and clinical operations departments, including explaining legal and budgetary issues. Facilitates execution of contracts by company signatories. Maintains contract templates and site-specific files and databases. Trains and mentors less experienced staff on SOPs and ensures quality of team work products. Maintains and updates training material for site contract team. Acts as a communication liaison between site contracts staff and internal/external customers. Provides functional guidance and keeps teams aware of contract statuses or pending issues. Prepares correspondence as necessary. Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
Reviews and complies with SOPs and WIs; keeps training records updated and ensures timesheet compliance. Get to know Syneos Health Phone: 919 876 9300; Fax: 919 876 9360; Toll-Free: 866 462 7373 Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: jobs@syneoshealth.com. One of our staff members will work with you to provide alternate means to submit your application.
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Updated: Yesterday. Location: CHN-Client. Job ID: 25101923. Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong. Job Responsibilities
Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level. Leads (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials. Provides support to SSUL to agree on country template contract and budget. Produces site-specific contracts from country template. Provides support in submissions for proposed contract and budget for sites. Supports negotiation of budget and contract with sites via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. Reviews contracts for completeness and accuracy, and ensures corrections are appropriately made and documented. Supports business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings. Collaborates with Contract Managers and team members on active project management of ongoing contract issues; follows up on all outstanding contract issues. Supports generation of amended contract and/or budget documents as necessary, prepares contract management documentation for projects, and streamlines contract/proposal or internal processes; initiates and introduces creative ideas and solutions. Works within forecasted country/site contracting timelines, ensures compliance, and tracks milestone progress in real time. Collaborates with internal and external legal, finance, and clinical operations departments, including explaining legal and budgetary issues. Facilitates execution of contracts by company signatories. Maintains contract templates and site-specific files and databases. Trains and mentors less experienced staff on SOPs and ensures quality of team outcomes. Maintains and updates training material for site contract team. Acts as a communication liaison between site contracts staff and internal/external customers. Provides functional guidance and keeps teams aware of contract statuses or pending issues. Prepares correspondence as necessary. Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion. Reviews and complies with SOPs and Work Instructions (WIs); keeps training records updated and ensures timesheet compliance. Qualifications
BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience. Advanced degree preferred. High level of contracts management experience. Experience in a contract research organization or pharmaceutical industry essential. Strong knowledge of the clinical development process and legal and contracting parameters. Strong computer skills in Microsoft Office Suite. Customer focused with ability to manage challenging priorities and remain flexible and adaptable in stressful situations. Excellent understanding of clinical trial processes across Phases II-IV and ICH GCP. Good understanding of clinical protocols and study specifications. Excellent understanding of clinical trial start-up processes. Project management experience in a fast-paced environment. Good vendor management skills. Excellent written/oral communication, presentation, documentation, interpersonal skills and strong team orientation. Strong organizational skills with proven ability to handle multiple projects. Quality-driven with strong negotiating and problem-solving skills. Ability to mentor, lead and motivate junior staff. Provide quality feedback and contribute to training and Quality Assurance plans within SSU and update SOPs/WIs. Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within the Site Start-Up/Site ID job family are responsible for managing and executing the site identification process in accordance with regulations, SOPs, and project requirements. This includes completing and negotiating site confidentiality agreements (CDAs) and site information forms (SIFs) with sites, maintaining, reviewing, and reporting on site performance metrics, serving as the primary point of contact for investigative sites, and tracking the completion of site identification for sites. The role describes impact and contribution for individual contributors with responsibility in a professional or technical discipline, including potential management of junior staff. The description also notes the typical profile of an established and productive individual contributor. Description Site Contract Specialist II Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level. Leads (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials. Provides support to SSUL to agree on country template contract and budget. Produces site-specific contracts from country template. Provides support in submissions for proposed contract and budget for site. Supports negotiation of budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. Reviews contracts for completeness and accuracy, and ensures corrections are appropriately made and documented. Supports business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings. Work with Contract Managers and team members on active project management of ongoing contract issues; follows up on all outstanding contract issues. Supports generation of amended contract and/or budget documents as necessary, prepares contract management documentation for projects, and streamlines contract/proposal or internal processes; initiates and introduces creative ideas and solutions. Works within forecasted country/site contracting timelines, ensures compliance, and tracks milestone progress in real time. Collaborates with internal and external legal, finance, and clinical operations departments, including explaining legal and budgetary issues. Facilitates execution of contracts by company signatories. Maintains contract templates and site-specific files and databases. Trains and mentors less experienced staff on SOPs and ensures quality of team work products. Maintains and updates training material for site contract team. Acts as a communication liaison between site contracts staff and internal/external customers. Provides functional guidance and keeps teams aware of contract statuses or pending issues. Prepares correspondence as necessary. Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
Reviews and complies with SOPs and WIs; keeps training records updated and ensures timesheet compliance. Get to know Syneos Health Phone: 919 876 9300; Fax: 919 876 9360; Toll-Free: 866 462 7373 Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: jobs@syneoshealth.com. One of our staff members will work with you to provide alternate means to submit your application.
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