Clinical Data Associate III (Medidata Rave)

Description

Note: Kindly refer Qualification Requirements section for key skills before applying.

Clinical Data Associate III (Medidata Rave)

Location: Mumbai & Pune Home-based only.

Syneos Health® 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’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.
  
  

Job Responsibilities

• Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager and/or Biometrics Project Manager as necessary.
• Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).
• Creates and enters test data for User Acceptance Testing (UAT)
• Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study and Targeted Source Data Verification (SDV) configuration and matrices.
• Receives and enters lab normal ranges.
• Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets.
• Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the Data Validation Specification and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries and re-queries where appropriate.
• For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly. Submits copies of the DCFs to sponsors as necessary.
• For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies.
• For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.
• For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable electronic data capture (EDC) systems.
• Creates electronic storage media per SOPs for EDC studies.
• Participates in internal meetings and internal/external audits as required.
• Files documentation in the Data Management Study File (DMSF).
• Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College).
• Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs.
• Coordinates the work of CDAs assigned to the project.
• Provides training on data management activities and systems.
• Provides project-specific training to other Clinical Data Associates (CDAs).
• Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party.
• 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 when issuing and resolving queries.
• Runs data cleaning and/or status reports.
• Performs Serious Adverse Event (SAE) reconciliations.
• Performs peer review to other CDAs and provides feedback.
• Understand how data management interacts with other Data Operations teams (Safety, Medical Writing, Biostatistics, Clinical Programming, and Coding).
• Performs QC of Data Dictionary for code lists
• Creates ad-hoc data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing (updates DVS with the listing requirements).
• Performs post-migration testing on screens, edit checks, matrices and role changes as required.
• Participates in customer and third party meetings distributing relevant information in advance, ensures minutes are promptly and accurately distributed to internal team for review and subsequent edits are applied in order to maintain established currency for sponsor distribution.
• Reviews database design specifications (including configuration, data structures, annotated CRFs).
• Designs and/or reviews CRF/eCRF including eCRF visit structure co-coordinating with team members responsible for the associated database design.
• Provides input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms including any post-production updates to the DVS and listings under guidance.
• Project Data Manager (PDM) back up for specific activities (including attend sponsor’s meetings to provide updates).
• Creation of Discoverer, BOXI, J-Review Reports.
• Updates the Data Management Plan under the guidance of the PDM.
• Supports PDM on updating documents (DMP, data import/export agreements) according to Trusted Process (TP).
• Creates and updates the CRF/eCRF Completion Guidelines.
• May fill-in the Data Transfer Request Form required for delivering the data to sponsor or vendor.
• Understands the coding process
• Understands the purpose of interim, dry run, data cut.
  
  

Qualifications

What we’re looking for

• BA/BS degree in the biological sciences or related disciplines in the natural science/health care field.
• Minimum 4 years of experience with Clinical Data Management practices and relational database management software systems preferred.
• Looking for good experience in Conduct (Query Management, Experience with Spotfire, Vendor & SAE Reconciliation, Experience with Lab query management added advantage), Closeout (DB Lock, Freezing & Locking), Startup experience preferred (UAT, Migrations, DM Documentation - DMP, DVS, eCRF completion guidelines).
• Minimum 1 year of experience with Medidata Rave, in following Therapeutic Area: Handson exposure of Oncology trials would be preferred, additionally other TA's like: Cardiovascular, Neurology, Respiratory, Infectious disease, Gastroenterology. Knowledge of clinical data, and ICH/Good Clinical Practices. Knowledge of medical terminology preferred.
• Client facing experience if any (either as a Point of contact for Study activities) would be an advantage
• 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 terminology.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Good 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.
• 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.