Description

Associate Director, Clinical Systems Super User

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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®.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

* We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
* We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
* We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

As part of the 'Clinical Stack Program', Syneos Health Clinical is deploying a fully integrated platform supporting the management and oversight of clinical trial monitoring and document management process; leveraging industry leading SaaS solution partners. The Clinical Stack Program will transform our business by streamlining processes; reducing costs and enabling InVentiv to consistency exceed client expectations.

Summary:

As a member of the Clinical Stack Super User Team, the Super User will provide business process and administrative support for the program; providing expertise to facilitate successful operations and management of clinical trials.

The Super User will participate in the development of user requirements, application testing, provide user training, prepare user documentation and assist in the resolution of system & user issues; using critical thinking skills to identify and resolve issues related to system usage.

Work Performed

* Act as central point of contact for end users for resolution of operational, process and advanced questions about system navigation and functionality (example: data setup, site management, site monitoring, templates, filing, reporting, etc.).
* Provide business process and system expertise to support clinical project teams and functional teams regarding proper use of the systems in compliance with InVentiv's Standard Operating Procedures (SOPs).
* Provide recommendations and offer guidance regarding issues/questions.
* Serve as subject matter expert (SME) and resource for other super users.
* Promote and facilitate efficient use of the systems.
* Identify potential problems and/or inconsistencies, take action as appropriate and make recommendations to prevent recurrences. Conduct project set up activities and configurations, ensuring project teams understand functionality and comply with InVentiv's standards.
* Assist with the development and maintenance of Data Entry Guidelines; ensure data quality standards are maintained.
* Partner with Tier 1 and 2 support teams to ensure warm hand-off of user issues and quick issue resolution.
* Identify and troubleshoot issues related to system functioning and/or inconsistencies in system use and make recommendations for resolution.
* Independently review and process assigned data change requests.
* Perform system configuration as assigned or escalate to Line Manager as needed.
* Meet SLAs and ad hoc project and cross project queries from trial teams and management with minimal guidance.

Perform basic and advanced system administration tasks, providing direction and resolving issues related to but not limited to:

* User administration
* Maintenance, review and set up of study, sponsor, investigator, site, vendor and contact lists
* Maintaining LOV's
* Creation/maintenance/requirements for templates & reports
* Creation of ad hoc reports

Job Description

* Partner with IT Support to ensure appropriate triage and resolution path for all technical and non-technical user issues
* Serve as escalation and central resolution point; ensuring usage and set up is in compliance with InVentiv SOPs, Work Instructions, Training and Policies.
* Provide end users resolution for issues pertaining to system usage, navigation and functionality - meeting established resolution targets and promoting efficient and consistent usage of the Clinical Stack Systems.
* Drive continuous improvements in support process through metrics and root cause analysis.
* Deliver training and/or serve as subject matter expert during training for end users.
* Assist in the development, maintenance, and revision of user and instructor led training materials and other user support documentation tools (e.g. FAQs, quick reference cards, release updates).
* Follow established processes (e.g., SOP, Work Instructions, Work Practices, Guidelines, etc.), as well as provide direction in the collection, entry, integrity and maintenance of global and/or master data.
* Develop and maintain systems specific processes (e.g., SOP, Work Instructions, Work Practices, Guidelines, etc.); Recommend revisions and/or creation of new processes to improve efficiencies.
* Prepare and/or review and distribute communications to end users.
* Conduct User Acceptance Testing (UAT) for system change requests, report requests and new functionality.
* Build and maintain effective working relationships with end users.
* Perform other related duties incidental to the work described herein.
* Maintain Data Quality standards and conduct data quality reviews

Qualifications

Preferred Experience

Clinical trials research experience (CRA, Doc Management, or other roles) with hands on experience using CTMS, eTMF and/or eDC systems (Medidata CTMS, Veeva Vault eTMF and Rave/Inform/other EDC experience a plus)

OR

Minimum of two plus years providing end user operational support of a Clinical Trials Management System (CTMS), preferably Medidata CTMS; or two plus years providing end user operational support of an Electronic Trial Master Files System (eTMF), preferable Veeva Vault eTMF. (Note: this must be end user business process support, not IT technical support experience)

Minimum Qualifications

As a healthcare company we have an important responsibility to protect individual and public health. Except in those locations where state or local law impacts this vaccination requirement, this position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities unless an exemption can be confirmed based on a medical condition, sincerely-held religious belief, or other reasons recognized by applicable law. Submission and approval of an exemption request does not necessarily guarantee that an accommodation can be provided for any specific job.

Candidates/Applicants that Reside in TN

Tennessee law prohibits private employers (such as Syneos Health) from requiring employees/candidates to present proof of vaccination. Tennessee courts have interpreted this restriction to mean that employers are prohibited from taking any adverse action against unvaccinated employees/candidates due to their unvaccinated status. Syneos will not take an adverse action (i.e., refuse to hire a candidate) because the candidate is unwilling to provide proof of vaccination.

* BA or BS degree
* Experience in CRO or Pharmaceutical industry
* Ability to prioritize activities effectively to accomplish individual and team goals with competing deadlines
* Ability to write and speak clearly and concisely in a variety of communication settings and styles
* Strong interpersonal skills; ability to establish and promote positive business relationships; customer service oriented
* Ability to collaborate with study staff and internal and external partners to achieve goals
* Proficient computer skills including use of MS Office Suite (Word, Excel, PowerPoint) and enterprise clinical trial management systems
* Strong organizational skills and attention to detail
* Strong problem analysis and resolution skills
* Knowledge of site management and clinical monitoring for clinical research studies

Note: This job description is not intended as a full list of all applicable job functions, including all physical or mental functions. Employees may be asked by supervisors or management to perform other duties. The employer has the right to revise this job description at any time.

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