Precision for Medicine

Global CRO for precision medicine trials

Clinical Data Associate 2

Clinical Research OperationsPosted on Nov 10

Full-timeBengaluru, Karnataka, IndiaNo salary listedIn-person

About the Job

Requirements

A bachelor's degree or a combination of related experience is required.
Two to four years of experience is required.
Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook is required.
Ability to handle a variety of clinical research tasks is required.
Professional written and oral use of English is required.

Responsibilities

Provide data management support across clinical trial data management from study start-up through post-database lock for assigned projects under direct supervision, following standard operating procedures, regulatory directives, and study-specific plans and guidelines.
Support the Lead Data Manager as a backup or team member to ensure continuity, responsiveness, and timely completion of tasks.
Perform data entry for paper case report form studies and quality control of data entry as needed.
Develop case report form specifications from the clinical study protocol and coordinate stakeholder review and feedback as needed.
Assist in building clinical databases; conduct database build user acceptance testing and maintain quality-controlled database build documentation.
Assist in specifying requirements for electronic, manual data review, and other edit checks.
Create, revise, version, and maintain data management documentation.
Train clinical research personnel on study-specific case report forms, electronic data capture, and other project-related items as needed.
Review and query clinical trial data according to the Data Management Plan.
Assist in reviewing line-listing data according to sponsor or Lead Data Manager guidance.
Run patient- and study-level status and metric reporting.
Perform medical coding of medical terms to ensure medical logic and consistency.
Assist with coordinating serious adverse event and adverse event reconciliation.
Assist in liaising with third-party vendors, including external data and electronic data capture vendors, in a project-management capacity to support timelines and data-related deliverables.
Assist with SAS programming and quality control of SAS programs used in the Data Management department as needed.
Assist in identifying and troubleshooting operational problems, issues, obstacles, and barriers for studies using metrics data, audit reports, and input from project team members and stakeholders.
Assist in reviewing and providing feedback on protocols, Statistical Analysis Plans, and Clinical Study Reports when required by a project.
Assist in developing and maintaining standard operating procedures and related process documentation for data management and database management activities.
Communicate with study sponsors, vendors, and project teams about data, database, and other relevant project issues as needed.
Present software demonstrations or training, department or company training sessions, and project meeting presentations as needed.
Travel as required.
Perform other duties as assigned.

Desired Qualifications

Experience in a clinical, scientific, or healthcare discipline is preferred.

Position Summary:

The Clinical Data Associate II provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position may perform database development and testing, as well as additional data management activities.

Essential functions of the job include but are not limited to:

Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner
May perform data entry for paper-CRF studies, as needed
May perform quality control of data entry
May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
May assist in building clinical databases
Conduct database build UAT and maintain quality controlled database build documentation
Assist in specifying requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.
Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed
Review and query clinical trial data according to the Data Management Plan
Assist in line listing data review based on the guidance provided by the sponsor and/or Lead DM
Run patient and study level status and metric reporting
Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
Assist with coordinating SAE/AE reconciliation
Assist with liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
May assist with SAS programming and quality control of SAS programs used in the Data Management department
May assist in identifying and troubleshooting operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
May assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
May present software demonstrations/trainings, department/company training sessions, present at project meetings
May require some travel
Perform other duties as assigned

Qualifications:

Minimum Required:

Bachelors and/or a combination of related experience

Other Required:

2 to 4 years’ experience
Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
Able to handle a variety of clinical research tasks
Excellent organizational and communication skills
Professional use of the English language; both written and oral

Preferred:

Experience in a clinical, scientific or healthcare discipline

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].

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Candidates must be legally authorized to work in the country of employment without employer sponsorship.

About the Company

Precision for Medicine

Global CRO for precision medicine trials

Precision For Medicine is a global clinical research organization (CRO) that helps life sciences companies run clinical trials from early to regulatory approval. It specializes in precision medicine, focusing on oncology, cell and gene therapy, and rare diseases. The company combines clinical trial services with specialty laboratory work and data sciences to improve speed, reduce costs, and increase the likelihood of success in bringing therapies to patients. It differentiates itself by integrating advanced technologies and data-driven biostatistics with specialized labs to support end-to-end trials across all stages. Its goal is to enable faster, more cost-efficient development of targeted therapies that meet regulatory requirements and reach patients in need.

Company size: 1,001-5,000
Company stage: Growth Equity (Venture Capital)
Total funding: $225M
Headquarters: Bethesda, MD
Founded: 2012

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