Qureos Mentor

Syneos Health

<div>Description
Stat II/ Senior/ Principal Stat Programmer (R / R Shiny)
Syneos Health&reg; 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&rsquo;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<ul><li>
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.</li><li>
We are committed to our Total Self culture &ndash; 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.</li><li>
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 &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<ul><li>
Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements.</li><li>
Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. &middot; Keeps project team members informed of programming progress and issues requiring their attention.</li><li>
Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).</li><li>
Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.</li><li>
Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.</li><li>
Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.</li><li>
Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.</li><li>
Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.</li><li>
Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions.</li><li>
Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables.</li><li>
Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.</li><li>
Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.</li><li>
Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.</li><li>
Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions.</li><li>
Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures.</li><li>
Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.</li><li>
When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards</li><li>
When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML)</li><li>
When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards.</li><li>
Transfers deliverables.</li><li>
Performs other work-related duties as assigned.</li><li>
Minimal travel may be required</li></ul>
Qualifications:<ul><li>
Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.</li><li>
Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers.</li><li>
Knowledge and experience in the use of CDISC Standards for regulatory agency requirements Experience in submissions to a regulatory agency preferred.</li><li>
Experience in mentoring others in clinical trial process and CDISC Standards.</li><li>
Excellent written and verbal communication skills.</li><li>
Ability to read, write, speak and understand English.</li></ul>
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&rsquo;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 Statistical Programming job family are responsible for developing programs and providing statistical programming support for statisticians or for client or business use to address needs for sourcing, organizing (creating statistical tables, listings, and graphs), and interpreting complex data sets utilizing codes and programs. This includes developing codes that create analysis datasets, tables, and figures, evaluating programming processes, and suggesting revisions geared toward increasing productivity.Impact and ContributionIndividual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Leading expert individual contributor who is viewed as a valuable resource by peers. Works to achieve organizational, functional, and/or business targets with measurable impact on department results. Manages or contributes to projects, programs, or processes that span multiple related areas. Comprehensive knowledge and skills in a professional discipline, understanding the impact of work on related areas.</div>

Stat II/ Senior/ Principal Stat Programmer (R / R Shiny)

<div>Description
Sr Medical Writer (Regulatory Documents)
Syneos Health&reg; 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&rsquo;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<ul><li>
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.</li><li>
We are committed to our Total Self culture &ndash; 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.</li><li>
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 &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<ul><li>
Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately</li><li>
Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision</li><li>
Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings</li><li>
Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides</li><li>
Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately</li><li>
Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format</li><li>
Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs</li><li>
Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables</li><li>
Perform online clinical literature searches and comply with copyright requirements</li><li>
Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff</li><li>
Mentor and lead less experienced medical writers on complex projects</li><li>
Develop deep expertise on key topics in the industry and regulatory requirements</li><li>
Work within budget specifications for assigned projects</li></ul>
Qualifications:<ul><li>
Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred</li><li>
3-5 years of relevant experience in science, technical, or medical writing</li><li>
Experience working in the biopharmaceutical, device, or contract research organization industry required</li><li>
Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required</li><li>
Experience writing relevant document types required</li><li>
Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style</li></ul>
Necessary Skills:<ul><li>
Strong presentation, proofreading, collaborative, and interpersonal skills</li><li>
Strong project and time management skills</li><li>
Strong proficiency in MS Office</li><li>
Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information</li></ul>
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&rsquo;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 Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility.Impact and ContributionRoles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format.Core Focus&bull;Leading the clear and accurate completion of medical writing deliverables&bull;Managing medical writing activities associated with individual studies&bull;Coordinating these activities within and across departments&bull;Completing a variety of documents, adhering to established regulatory standards&bull;Coordinating quality and editorial reviews&bull;Acting as peer reviewers for the internal team&bull;Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency&bull;Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs&bull;Performing online clinical literature searches and complying with copyright requirements&bull;Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff&bull;Mentoring and leading less experienced medical writers on complex projects&bull;Developing deep expertise on key topics in the industry and regulatory requirements&bull;Working within budget specifications for assigned projects</div>

Sr Medical Writer (Regulatory Documents)

<div>Description
Sr Clinical Data Scientist
Syneos Health&reg; 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&rsquo;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<ul><li>
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.</li><li>
We are committed to our Total Self culture &ndash; 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.</li><li>
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 &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<h1 class="jobSectionHeader">
Shift Time: 4:30 PM to 1:30 AM IST</h1><h2 class="jobSectionHeader"> 

Job Summary</h2> 
Responsible for the end-to-end coordination of cross functional data collection and cleaning activities to ensure clinical study data deliverables are fit for purpose and align with the executed contract and sponsor expectations and timelines.<h2 class="jobSectionHeader"> 
Core Responsibilities</h2><ul><li>Serves as Functional Lead for Clinical Data Science including primary contact for internal liaison between Clinical Data Science and Project Management, Clinical Monitoring, and other functional groups</li><li>Acts as central steward of clinical data quality, monitors risks through the holistic review of clinical and operational data, using high level knowledge of the protocol, taking into account the specific therapeutic area aspects of the protocol related to the data collected and aligning with cross functional operational plans to drive comprehensive clinical data quality</li><li>Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysis</li><li>Works with assigned project teams to communicate, address, troubleshoot and resolve data related questions and recommends potential solutions; escalates issues which potentially impact patient safety and study analysis</li><li>Coordinates cross functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverables Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined project analysis</li><li>Drives the development of the clinical data acquisition plan and corresponding data flow diagram with the study team, assess risks associated with protocol design, study set parameters that could impact the credibility and reliability of the trial results, aligns data flow with the study protocol to ensure data collected meets regulatory and study endpoint requirements.</li><li>Drives the development of analytical tools, utilizes analytical platform/dashboard to detect potentially unreliable data that may impact the validity of the trial results Performs analytic reviews as defined in scope of work and data acquisition plan, identifies root cause to systematically resolve data issues</li><li>Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics</li><li>Ensures launch, delivery and completion of all Clinical Data Sciences activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations</li><li>Review, maintain budget and identify out of scope for Clinical Sciences activities, raise to PM to be implemented in required change order</li><li>Plans, manages, and requests Clinical Data Science resources for assigned projects</li><li>Coordinates the work of the assigned Clinical Data Science team</li><li>Develops and maintains project plans, specifications, and documentation in line with SOP requirements</li><li>Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date for necessary files</li><li>Participates in, and presents at internal, Sponsor, third-party, and investigator meetings on behalf of clinical data science responsibilities</li><li>Prepares input, and participates in proposal bid defense meetings and request for proposals on behalf of clinical data science responsibilities</li><li>Plans for and creates necessary documentation to support internal and external audits; participates in such audits on behalf of clinical data sciences responsibilities</li><li>Trains and mentors new or junior team members</li><li>Maintains proficiency in Clinical Data Science systems and processes through regular training. May attend/represent the company at professional meetings/conferences</li><li>Performs other work-related duties as assigned. Minimal travel may be required (up to 25%)</li></ul><h2 class="jobSectionHeader"> 
Additional Qualifications</h2><ul><li> 
BA/BS in the biological sciences, computer sciences, mathematics, or data sciences and/or related disciplines in the natural science/health care space. MS degree is preferred. In lieu of degree, equivalent relevant work experience</li><li>Clinical Data Science experience or an equivalent combination of education and experience</li><li>Experience in Clinical Data Science practices and relational database management software systems</li><li>Strong knowledge of the drug development process and its impact on data quality, in particular risk-based approach, biometrics procedures, workflows.</li><li>Aptitude for understanding analytic modeling methods such as regression, classification and clustering</li><li>Strong project management skills and knowledge of project management methodologies</li><li>Strong analytical skills and knowledge of Artificial intelligence /machine learning methodologies preferred</li><li>Demonstrated staff leadership skills</li><li>Knowledge of ALCOA++ data quality principles</li><li>Strong experience with protocol interpretation, data collection and data cleaning specification development</li><li>Experienced with data analysis/data review and visualization tool sets including but not limited to Python, R, Spotfire, SAS</li><li>Knowledge of medical terminology, clinical data, and ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Sciences</li><li>Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications</li><li>Effective oral and written communication and presentation skills</li><li>Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail</li><li>Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team</li><li>Ability to make effective decisions and manage multiple priorities in a highly dynamic environment</li></ul>
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&rsquo;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
Responsible for the end-to-end coordination of cross functional data collection and cleaning activities to ensure clinical study data deliverables are fit for purpose and align with the executed contract and sponsor expectations and timelines.</div>

Sr Clinical Data Scientist

<div>Description
Site Contracts Specialist II
Syneos Health&reg; 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&rsquo;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<ul><li>
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.</li><li>
We are committed to our Total Self culture &ndash; 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.</li><li>
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 &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<ul><li>
Manage and execute the site identification process in accordance with regulations, SOPs, and project requirements, ensuring timely and accurate completion of all tasks</li><li>
Complete and negotiate site confidentiality agreements (CDAs) and site information forms (SIFs) with sites, ensuring compliance with legal and regulatory requirements</li><li>
Maintain, review, and report on site performance metrics, identifying areas for improvement and implementing corrective actions as needed</li><li>
Serve as the primary point of contact for investigative sites, providing support and guidance throughout the site identification process</li><li>
Track the completion of site identification for sites, ensuring all necessary documentation is collected and maintained</li><li>
Contribute to the design, implementation, or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education</li><li>
May manage defined components of projects or processes within area of responsibility, ensuring project milestones and deliverables are met</li><li>
Direct the work of support roles or manage processes and programs, providing mentorship and guidance to team members</li></ul>
Qualifications:<ul><li>
Bachelor's degree in a relevant field or equivalent experience</li><li>
Practical knowledge of a professional area, typically obtained through education combined with experience</li><li>
Established and productive individual contributor</li></ul>
Certifications:<ul><li>
Relevant certifications in clinical research or site management preferred</li></ul>
Necessary Skills:<ul><li>
Strong negotiation and communication skills</li><li>
Ability to manage multiple tasks and projects simultaneously</li><li>
Proficiency in maintaining and reviewing performance metrics</li><li>
Excellent organizational and time management skills</li><li>
Ability to work independently and as part of a team</li><li>
Knowledge of regulations, SOPs, and project requirements related to site identification</li></ul>
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&rsquo;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 at the P21 level are responsible for managing and executing the site identification process in accordance with regulations, SOPs, and project requirements. These roles involve 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.Impact and ContributionIndividuals in these roles are established and productive contributors who may manage defined components of projects or processes within their area of responsibility. They utilize their practical knowledge of the professional area, typically obtained through education combined with experience, to contribute to the design, implementation, or delivery of processes, programs, and policies. Their work ensures that site identification processes are completed efficiently and effectively, supporting the overall success of clinical trials and research projects.Core Focus&bull;Managing and executing the site identification process in accordance with regulations, SOPs, and project requirements&bull;Completing and negotiating site confidentiality agreements (CDAs) and site information forms (SIFs) with sites&bull;Maintaining, reviewing, and reporting on site performance metrics&bull;Serving as the primary point of contact for investigative sites&bull;Tracking the completion of site identification for sites</div>

Site Contracts Specialist II

<div>Description
Senior Clinical Programmer (DM SAS)
Syneos Health&reg; 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&rsquo;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<ul><li>
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.</li><li>
We are committed to our Total Self culture &ndash; 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.</li><li>
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 &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<ul><li>
Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. 
Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports..</li><li>
Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.</li><li>
Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports</li><li>
Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions.</li><li>
Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with inprogress audits.</li><li>
Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders.</li><li>
Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed.</li><li>
Performs system integration activities, application updates, and user acceptance testing.</li><li>
Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs.</li><li>
Assists in project meetings and actively contributes and participates in departmental review meetings. Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies.</li><li>
Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements.</li><li>
Manages project resources, proactively alerting management of delivery and resourcing needs.</li><li>
Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.</li></ul>
Qualifications:<ul><li>
Bachelor&rsquo;s degree preferred, or equivalent combination of related education and experience.</li><li>
Must have minimum 5+years of experience in Clinical Programming</li><li>
Experience in listings programming &amp; creating Macros, Study build and SAS Mapping experience is preferable</li><li>
Data Acquisition &ndash; Experience in CDSIC Data Mapping, External/Vendor Data Mapping and DIA is preferable.</li><li>
Good Communication skills</li><li>
Preferred Base and Advanced SAS certification</li><li>
Exp on any Therapeutic areas is okay</li><li>
Ability to deal effectively with sponsors and internal customers at all levels.</li><li>
Excellent communication and interpersonal skills, both written and spoken, with an ability to inform.</li><li>
Demonstrated experience in managing multiple priorities in a highly dynamic environment</li><li>
Experience working in a matrix-structured environment is preferred</li><li>
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail</li><li>
Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred.</li><li>
Ability to travel as necessary (up to 25%)</li></ul>
We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
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&rsquo;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
Serves as lead Clinical Programmer to manage and support project deliverables and timelines. Designs, writes, validates and maintains software to meet specifications. Specifies, develops and validates applications supporting data capture and processing. First level technical Subject Matter Expert (SME), supports the production-line clinical programming and data management staff in a support desk role for Electronic Data Capture (EDC), reporting, and processing tools. Assists in monitoring internally and externally hosted applications for performance and/or system errors. Assists support team with customers as needed to support projects and applications externally. Assists with management of external application vendor issues, integrations and implementations.</div>

Senior Clinical Programmer (DM SAS)

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