Senior Clinical Data Associate - (Technical Designer) Full-time Job

Description

Senior Clinical Data Associate - Technical Designer

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.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

Why Syneos Health

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

Role Summary This position is responsible for providing focused expertise and full responsibility for database build and set up. 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 accordance with the executed contract and the Sponsor's expectations. The scope may include projects that are large and/or complex and/or with particular challengeThis position is responsible for coordinating with other technical designers (TD) in all start up and build activities, providing support. Job responsibilities Attends Client Study Start-up Kick-off meetingParticipates in internal meetings, including UAT Kick-off meeting.Attends in-process review meetings. Attend and present CRFs in the eCRF walkthrough meeting to the client.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 structure cocoordinating with team members responsible for the associated database design.Create the Study Logic and Configuration Specification (SLACS) including creation of edit checks for assigned 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 teams and project teams in accordance with CDISC standardsLiaises 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 soliciting support from and coordinating with other Technical Designers, taking full responsibility for study startup activities. PDM's back up for specific activities (including attending sponsor's meetings to provide status updates).Files documentation in the Data Management Study File (DMSF).Performs QC of DMSF after Go-LiveUnderstands the coding, DCH, IxRS integration, UAT/SDTMv test entry, Non-CRF, SDCRe processServes 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 projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to project team and management, accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on 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. Maintains proficiency in Data Management systems and processes through regular trainings and reference to client SOPs and process repository as well as data standardsTrains 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 the study 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.5 - 8 years of relevant experience in Technical designing.Experience in designing of Build/eCRF from DM standpoint.Strong experience in Startup. Experience with Amendments & migrations in Conduct Phase.Experience in EC Specification, CRF/eCRF Completion Guidelines, Spotfire visualization specifications (SVS), Study Configuration Document (SCD).Experience in Rave EDC.Knowledge of clinical data, and ICH/Good Clinical Practices. Knowledge of medical terminology preferred.Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications. Excellent speed and accuracy of keyboard skills.Work experience in clinical research, drug development, data management, or other healthcare environment preferred.Familiarity with medical terminologyExcellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuadeGood organizational, planning, and time management skills preferred. Ability to multitask under tight deadlines while providing attention to detail. Ability to be flexible and adapt to change. Ability to work independently as well as part of a multi-disciplinary team.Ability to perform a leadership functions in DM including effective mentoring skills, and the ability to deal effectively with sponsors and internal customers.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

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

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.