Sr Clinical Data Manager (Hybrid - Serbia, Poland, Spain, South Africa, Hungary, CZ, Ukraine, Romania) Veeva CDMS and Veeva CDB - Required

Sr Clinical Data Manager (Hybrid - Serbia, Poland, Spain, South Africa, Hungary, CZ, Ukraine, Romania) Veeva CDMS and Veeva CDB - Required

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

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 deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

***This position is open to hybrid (in office 2x per week)***

***Hands on experience with Veeva CDMS and Veeva CDB is a requirement

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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

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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

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Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysis

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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

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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

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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.

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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

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Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics

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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

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Review, maintain budget and identify out of scope for Clinical Sciences activities, raise to PM to be implemented in required change order

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Plans, manages, and requests Clinical Data Science resources for assigned projects

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Coordinates the work of the assigned Clinical Data Science team

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Develops and maintains project plans, specifications, and documentation in line with SOP requirements

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Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date for necessary files

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Participates in, and presents at internal, Sponsor, third-party, and investigator meetings on behalf of clinical data science responsibilities

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Prepares input, and participates in proposal bid defense meetings and request for proposals on behalf of clinical data science responsibilities

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Plans for and creates necessary documentation to support internal and external audits; participates in such audits on behalf of clinical data sciences responsibilities

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Trains and mentors new or junior team members

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Maintains proficiency in Clinical Data Science systems and processes through regular training. May attend/represent the company at professional meetings/conferences

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Performs other work-related duties as assigned. Minimal travel may be required (up to 25%)

REQUIREMENTS

• BA/BS in the biological sciences, computer sciences, mathematics, or data sciences and/or related disciplines in the natural science/health care space.

• Hands on experience with Veeva CDMS and Veeva CDB is a requirement

• Clinical Data Science experience or an equivalent combination of education and experience
• Experience in Clinical Data Science practices and relational database management software systems
• Strong knowledge of the drug development process and its impact on data quality, in particular risk-based approach, biometrics procedures, workflows.
• Aptitude for understanding analytic modeling methods such as regression, classification and clustering
• Strong project management skills and knowledge of project management methodologies
• Demonstrated staff leadership skills
• Knowledge of ALCOA++ data quality principles
• Strong experience with protocol interpretation, data collection and data cleaning specification development
• Experienced with data analysis/data review and visualization tool sets including but not limited to Python, R, Spotfire, SAS
• Knowledge of medical terminology, clinical data, and ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Sciences
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications
• Effective oral and written communication and presentation skills
• Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail

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.

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.