Sr CDA - (Technical Designer) - 2nd shift

Sr CDA - (Technical Designer) - 2nd shift

inVentiv Health Clinical SRE, LLC
5-8 years
Not Specified

Job Description


Job Description :
Senior Clinical Data Associate - (Technical Designer)
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health
. #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
. We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job Summary
This position is responsible for providing focused expertise and full responsibility for database build and setup.
. Responsible for executing all study build activities for the assigned projects.
. Ensures the contracted start up activities for projects are carried out by the Company in accordancewith the executed contract and the Sponsor's expectations. The scope may include projects that arelarge and/or complex and/or with particular challenge
. This position is responsible for coordinating with other technical designers (TD) in all start up and buildactivities, providing support.
Job responsibilitiesAttends Client Study Start-up Kick-off meeting
. Participates in internal meetings, including UAT Kick-off meeting.
. Attends in-process review meetings. Attend and present CRFs in the eCRF walkthrough meeting to theclient.
. Creates/Reviews Study Build timelines and provide inputs as applicable to the PDM.
. Exhibits thorough knowledge and interpretation of the study protocol for Study startup activities.
. Creates and/or reviews database design specifications (including configuration, data structures,annotated CRFs).
. Designs and/or reviews CRF/eCRF, Matrix Design document (MDD) including eCRF visit structurecocoordinating with team members responsible for the associated database design.
. Create the Study Logic and Configuration Specification (SLACS) including creation of edit checks forassigned forms including any post-production updates to the DVS and listings under guidance.
. Creates, updates and reviews study-specific documents such as CRF/eCRF Completion Guidelines,Spotfire visualization specifications (SVS), Study Configuration Document (SCD).
. Supports, maintains and utilizes Data Standardization of eCRF and eCRF modules, data collection,data quality rules, data libraries and dictionaries in conjunction with inputs from other functional teamsand project teams in accordance with CDISC standards
. Liaises with other groups such as Clinical Programming (CP), Biostatistics and Clinical Operations.
. Provides study startup process expertize to the PDM on a study as required. May involve solicitingsupport from and coordinating with other Technical Designers, taking full responsibility for study startupactivities. PDM's back up for specific activities (including attending sponsor's meetings to provide statusupdates).
. Files documentation in the Data Management Study File (DMSF).
. Performs QC of DMSF after Go-Live
. Understands the coding, DCH, IxRS integration, UAT/SDTMv test entry, Non-CRF, SDCRe process
. Serves as a Study startup- Subject Matter Expert (SME).
. During post-production activities, provides support to the PDM for study-specific document updates,such as CRF, MDD, SLACS, SVS, etc.
. Participates in internal/external audits as required.
. May be required to participate in client, internal or agency audits and inspections.
. Oversees the work of other Technical Designers as required. This may involve on-the-job training,review of work, as well as ensuring the quality of work performed.
. Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projectsand adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates toproject team and management, accurate estimates on time to complete tasks, availability to take onnew assignments and resourcing conflicts. Minimizes rework by following study instructions, seekingunderstanding of assignments prior to performing task and anticipating the effect changes may haveon data.
. Provides technical expertise to project teams in the operational tasks of data collection and support,ensuring consistency in study build to avoid redundancy, inefficiency, or potential problems. Maintainsproficiency in Data Management systems and processes through regular trainings and reference toclient SOPs and process repository as well as data standards
. Trains and mentors DM staff providing timely feedback to trainee and management as appropriate.
. May represent the department at business development related meetings.
. May function as a backup for the Project Data Manager (PDM) on the study startup activities of thestudy as required for global clinical trials Qualifications
What we're looking for
. BA/BS degree in the biological sciences or related disciplines in the natural science/health care field.
. Experience with DM practices and relational database management software systems preferred.
. Min 5 years of relevant experience.
. Experience in designing of Build/eCRF from DM standpoint.
. Strong experience in Startup.
. Experience in EC Specification, CRF/eCRF Completion Guidelines, Spotfire visualization specifications (SVS), Study Configuration Document (SCD).
. Experience in Rave EDC.
. Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications. Excellent speed and accuracy of keyboard skills.
. Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management. Minimal travel may be required (up to 25%).
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
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.

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