WFH Opportunity Syneos Health Hiring Clinical Data Associate Degree in the biological sciences or related disciplines in the natural science/health care field Apply Now
Clinical Data Associate I /II / III
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
JOB SUMMARY
This position is responsible for assisting in all clinical data management
activities required for complex
clinical trials with high proficiency and by providing guidance to other
Clinical Data Associates (CDAs).
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 requires 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.
QUALIFICATION REQUIREMENTS
BA/BS degree in the biological sciences
or related disciplines in the natural science/health care field.
· Minimum 2 to 5 years of
Experience with Clinical Data Management practices and relational database
management software systems preferred.
· Strong background in
conducting CDM activities.
· Must have experience in
Conduct & Closeout, preferably in Inform EDC.
· Conduct Exp: Discrepancy
Management, Vendor Recon, SAE, PK & PD, IVRS and lab, Data Cleaning, Manual
data review..
· Preferred to have startup
experience
·Therapeutic area: Preferably Vaccine & Oncology
·Good to have Experience in CPT/Metrics
· Strong communication skills.
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%).
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