Qureos Mentor

Syneos Health

<div>Description
Sr Tech Business Analyst
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.
Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life&reg;.
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">
Job Summary</h1> 
The Senior Tech Business Analyst is responsible for leading the analysis of complex business problems and guiding the design and implementation of advanced business solutions. This role collaborates with stakeholders, business partners, and vendors to implement and support solutions to optimize performance, drive savings, and enhance the company&rsquo;s competitive edge.<h1 class="jobSectionHeader">
Core Responsibilities</h1><div><ul><li> 
Identifies and documents emerging business requirements; Questions business partner and knowledge worker preferences to identify unique value drivers</li><li>Capture business requirements, functional and nonfunctional requirements. Create and maintain technical documentation, including specifications, user guides and reports</li><li>Prioritize competing business demands, elicit high-level business requirements, and assess the risks of various solution options to different options.</li><li>Communicate between business units, technology teams, and support teams, aligning the needs of business units with the capabilities delivered by information technology and serves as a &ldquo;translator&rdquo; between those groups.</li><li>Manages requirements to meet performance expectations</li><li>Facilitate communication between technical teams and non-technical business stakeholders to ensure alignment and clarity.</li><li>Present ideas in a concise, focused manner. Surface potential impacts of the solution on all stakeholders. Articulates the role of technology in terms easily understood by business constituencies.</li><li>Mentor and coach junior team members</li></ul></div><h1 class="jobSectionHeader">
Qualifications</h1>
Education Requirements 
Min/Preferred Education Level Description 
Minimum 4 Year / Bachelors 
Degree 
Bachelor&rsquo;s degree in computer science engineering or relevant degree.<h1 class="jobSectionHeader"> 
Additional Qualifications</h1><div><ul><li> 
Bachelor&rsquo;s degree in Life Sciences, Communications or related field.</li><li>Self-starter, proactive, strong-business acumen, excellent follow-through.</li><li>Primary Business Analyst on several medium to large complexity projects. (preferred)</li><li>Demonstrated ability to define business requirements and measure / communicate proposed</li></ul>
project benefits (preferred) 
<ul><li>Demonstrated knowledge of both traditional Waterfall and Agile/Lean methodologies.</li><li>Experience in converting business requirements and functional requirements to use cases, epics, and user stories with acceptance criteria. (preferred)</li><li>Demonstrated ability to engage both developers and business partners to achieve target outcomes</li><li>Excellent written and verbal communications; Solid written and oral presentation skills</li><li>Ability to keep control of the room in a way that is not off-putting; Natural ability to redirect and refocus conversations with people at different levels when needed</li><li>Ensures and advises business stakeholders by actively initiating and influencing what is needed versus how their needs will be achieved; Ability to drive change</li><li>Analytic Ability: ability to work with data to identify patterns; Uses judgment to form conclusions that may challenge conventional wisdom, and focuses on the crux of issues to identify high leverage intervention points and strategies</li><li>Exhibits high levels of engagement with stakeholders at all levels and understanding high depths of business context</li><li>Proficient with MS Office applications (e.g. Visio, Word, Excel, Power Point, etc.)</li></ul></div>
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.</div>

Sr Tech Business Analyst

<div>Description
Safety &amp; PV Specialist I (Literature Review)
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>
Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications, and testsCompiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.</li><li>
Maintains safety tracking for assigned activities.</li><li>
Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.</li><li>
Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.</li><li>
Manual recoding of un-recoded product and substance terms arises from ICSRs.</li><li>
Identification and management of duplicate ICSRs.</li><li>
Activities related to SPOR / IDMP.</li><li>
Quality review of ICSRs.</li><li>
Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.</li><li>
Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.</li><li>
Fosters constructive and professional working relationships with all project team members, internal and external.</li><li>
Participates in audits as required/appropriate.</li><li>
Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.</li></ul>
Qualifications:<ul><li>
Bachelor&rsquo;s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job.</li><li>
Minimum 2+ years of experience in Literature review</li><li>
Candidates with Literature review experience along with Literature Case Processing and Clinical Trial Case Processing exp are preferred</li><li>
Drug Safety Triager Database preferred for Literature experience</li><li>
Safety Database systems and knowledge of medical terminology required.</li><li>
Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.</li><li>
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.</li><li>
Ability to work independently and in a team environment.</li><li>
Excellent communication and interpersonal skills, both written and spoken.</li><li>
Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.</li><li>
Detail oriented with a high degree of accuracy and ability to meet deadlines.</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 Pharmacovigilance &amp; Safety job family are responsible for providing expertise on pharmacovigilance services. This includes participating in all aspects of the medical safety team's involvement in assigned trials, such as performing medical review and clarification of trial-related Adverse Events, providing aggregate reviews of safety information, and serving as an internal consultant to pharmacovigilance case processing teams. Provides and contributes trends and safety signal detection and risk management assessment and provides safety support to the clinical development teams.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. Entry to developing individual contributor. Delivers work of limited scope, typically smaller, less complex projects. Requires theoretical knowledge of a professional area, typically obtained through education and/or prior experience.</div>

Safety & PV Specialist I (Literature Review)

<div>
 
 Description
 
 
 
 Safety &amp; PV Specialist I (Literature Review)
 
 
 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>
 Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications, and testsCompiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
 </li>
 <li>
 Maintains safety tracking for assigned activities.
 </li>
 <li>
 Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
 </li>
 <li>
 Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
 </li>
 <li>
 Manual recoding of un-recoded product and substance terms arises from ICSRs.
 </li>
 <li>
 Identification and management of duplicate ICSRs.
 </li>
 <li>
 Activities related to SPOR / IDMP.
 </li>
 <li>
 Quality review of ICSRs.
 </li>
 <li>
 Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
 </li>
 <li>
 Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.
 </li>
 <li>
 Fosters constructive and professional working relationships with all project team members, internal and external.
 </li>
 <li>
 Participates in audits as required/appropriate.
 </li>
 <li>
 Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
 
 
 </li>
 </ul>
 
 Qualifications:
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job.
 </li>
 <li>
 Minimum 2+ years of experience in Literature review
 </li>
 <li>
 Candidates with Literature review experience along with Literature Case Processing and Clinical Trial Case Processing exp are preferred
 </li>
 <li>
 Drug Safety Triager Database preferred for Literature experience
 </li>
 <li>
 Safety Database systems and knowledge of medical terminology required.
 </li>
 <li>
 Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.
 </li>
 <li>
 Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.
 </li>
 <li>
 Ability to work independently and in a team environment.
 </li>
 <li>
 Excellent communication and interpersonal skills, both written and spoken.
 </li>
 <li>
 Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
 </li>
 <li>
 Detail oriented with a high degree of accuracy and ability to meet deadlines.
 
 
 </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 Pharmacovigilance &amp; Safety job family are responsible for providing expertise on pharmacovigilance services. This includes participating in all aspects of the medical safety team's involvement in assigned trials, such as performing medical review and clarification of trial-related Adverse Events, providing aggregate reviews of safety information, and serving as an internal consultant to pharmacovigilance case processing teams. Provides and contributes trends and safety signal detection and risk management assessment and provides safety support to the clinical development teams. Impact and Contribution Individual 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. Entry to developing individual contributor. Delivers work of limited scope, typically smaller, less complex projects. Requires theoretical knowledge of a professional area, typically obtained through education and/or prior experience.
</div>

<div>Description
Safety &amp; PV Specialist I
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>
Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications, and testsCompiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.</li><li>
Maintains safety tracking for assigned activities.</li><li>
Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.</li><li>
Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.</li><li>
Manual recoding of un-recoded product and substance terms arises from ICSRs.</li><li>
Identification and management of duplicate ICSRs.</li><li>
Activities related to SPOR / IDMP.</li><li>
Quality review of ICSRs.</li><li>
Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.</li><li>
Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.</li><li>
Fosters constructive and professional working relationships with all project team members, internal and external.</li><li>
Participates in audits as required/appropriate.</li><li>
Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.</li></ul>
Qualifications:<ul><li>
Bachelor&rsquo;s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job.</li><li>
Safety Database systems and knowledge of medical terminology required.</li><li>
Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.</li><li>
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.</li><li>
Ability to work independently and in a team environment.</li><li>
Excellent communication and interpersonal skills, both written and spoken.</li><li>
Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.</li><li>
Detail oriented with a high degree of accuracy and ability to meet deadlines.</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 Pharmacovigilance &amp; Safety job family are responsible for providing expertise on pharmacovigilance services. This includes participating in all aspects of the medical safety team's involvement in assigned trials, such as performing medical review and clarification of trial-related Adverse Events, providing aggregate reviews of safety information, and serving as an internal consultant to pharmacovigilance case processing teams. Provides and contributes trends and safety signal detection and risk management assessment and provides safety support to the clinical development teams.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. Entry to developing individual contributor. Delivers work of limited scope, typically smaller, less complex projects. Requires theoretical knowledge of a professional area, typically obtained through education and/or prior experience.</div>

Safety & PV Specialist I

<div>Description
Principal Tech Project Manager (must have: clinical experience, GxP)
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.
Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life&reg;.
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<h3 class="jobSectionHeader">
JOB RESPONSIBILITIES</h3><ul><li>
Oversee program execution to ensure adherence to budget, schedule, and scope. Drive large complex portfolio prioritization, planning, execution, actively managing risks and issues and communicating status in an objective manner to all stakeholders.</li><li>
Responsible for the overall planning, coordination, and execution of the program, managing interdependencies between projects, and optimizing resources across the program.</li><li>
Set program goals, define scope, track progress, and mitigate risks.</li><li>
Collaborate with stakeholders, project managers, and cross-functional teams to ensure that all projects within the program contribute effectively to the broader business strategy.</li><li>
Strong leadership, strategic thinking, and a deep understanding of Tech systems and business processes are essential for this role.</li><li>
Oversight of project managers for the planning and execution of a portfolio of varying complexity of product development.</li><li>
Sets and resets project/program/portfolio process procedures, timelines, and priorities with appropriate executive management approval.</li><li>
Establishes project procedures, rules, and guidelines; approves exceptions and modifications within own area of responsibility.</li><li>
Support Business Partner &amp; Product Manager in Benefits Management</li><li>
Manages relationships with technology vendors used for the different projects in the program including SOW/PO Management</li><li>
Analyzes the impact of changes in existing projects or addition of new projects and identifies strategies (resources allocation/project sequencing) for accomplishing all desired projects</li><li>
Build and maintaining strong relationships with stakeholders, understanding their needs, and addressing any concerns or issues that arise</li></ul>
QUALIFICATION REQUIREMENTS
<ul><li>Bachelor&rsquo;s Degree (BA/BS) in a technical discipline or relevant field</li><li>
Experience in program management, preferably in the healthcare or pharmaceutical industry</li><li>
Excellent communication and interpersonal skills, with the ability to effectively interact with clients, stakeholders, and team members</li><li>
Proven track record of successfully leading and delivering complex programs on time and within budget</li><li>
Extensive knowledge of project management tools and methodologies, experience using project management and business management computer software.</li><li>
Thorough understanding of budgeting, project management, and resource management</li><li>
Strong leadership skills with the ability to inspire and motivate teams to achieve excellence.</li></ul>
PMP certification or equivalent preferred
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
The Principal Project Manager is responsible for comprehensively developing and managing all components of the assigned portfolio of product development work which may include execution and management of critical cross-function and strategic initiatives for leadership. This role supports our business goals by serving as a liaison between business and technical aspects of programs to ensure delivery of intended outcomes.</div>

Principal Tech Project Manager (must have: clinical experience, GxP)

<div>Description
Pr Statistical Programmer-ADAM/TLF(Oncology)
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>

Pr Statistical Programmer-ADAM/TLF(Oncology)

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Pr Statistical Programmer-ADAM/TLF(Oncology)