Clinical Data Associate II REMOTE

2 weeks ago

Pune, Maharashtra, India Lifelancer Full time

About the job

Description

Clinical Data Associate II

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, youll 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 were 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).
  • 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 assigned data review listings, all different roles used in the study.
  • 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 in cases where queries are not required, per the Data Validation Specification (DVS) and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries correctly 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 Case Report Forms (CRFs) and 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 Electronic Data Capture (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).
  • Creates and enters test data for Standard Data Tabulation Model (SDTM) test data.
  • Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs.
  • May coordinate the work of CDAs assigned to the project.
  • May provide training on data management activities and systems.
  • 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.
  • Understands the coding process.
  • Understands the purpose of interim, dry run, data cut.

Qualifications

  • What were 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.
  • Oracle Clinical, Rave, or Inform systems preferred. 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 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%).

Please use the below link for job application and quicker response.

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