Precision for Medicine

Global CRO for precision medicine trials

Senior Clinical Data Manager

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeBengaluru, Karnataka, IndiaNo salary listed

About the Job

Requirements

A bachelor's degree or a combination of related experience is required.
At least 10 years of experience is required.
Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Outlook, is required.
Ability to handle a variety of clinical research tasks is required.
Professional use of English, both written and oral, is required.
Experience using various clinical database management systems is required.
Broad knowledge of drug, device, or biologic development and effective data management practices is required.
Strong representational skills and the ability to communicate effectively orally and in writing are required.
Strong leadership and interpersonal skills are required.
Ability to undertake occasional travel is required.

Responsibilities

Manage all aspects of the clinical trial data management process for assigned projects, from study start-up through post-database lock, following standard operating procedures, work instructions, regulatory directives, study-specific plans, and guidelines.
Serve as the primary data management contact and lead data manager for assigned clinical projects or programs, ensuring backup, continuity, responsiveness, and timely task completion; support another lead data manager as backup or team member and provide data management oversight of sponsor programs when applicable.
Oversee project data entry, including development of data entry guidelines, training, data entry quality, and resourcing; perform quality control of data entry when needed.
Provide input on timelines, assess and manage them, ensure clinical data management deadlines are met with quality, and assess project resource needs as needed.
Develop case report form specifications from the clinical study protocol and coordinate review and feedback from stakeholders.
Assist with building clinical databases as needed.
Conduct user acceptance testing of database builds, maintain quality-controlled database build documentation, and oversee overall clinical database quality.
Specify requirements for electronic and manual edit checks and other data review types as needed; oversee development of edit-check and manual data review specifications.
Create, revise, version, and maintain data management documentation; oversee completeness of data management documentation for the Trial Master File.
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.
Perform line-listing data review based on sponsor or lead data manager guidance.
Run patient- and study-level status and metric reporting.
Perform medical coding of medical terms relative to each other to ensure medical logic and consistency.
Coordinate serious adverse event and adverse event reconciliation.
Liaise 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 Statistical Analysis System programming and quality control of programs used in the Data Management department as needed.
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies using metrics data, audit reports, and input from project team members and stakeholders.
Review and provide feedback on protocols, Statistical Analysis Plans, and Clinical Study Reports when required by the project.
Participate in developing and maintaining standard operating procedures and process documentation for data management and database management activities.
Attend strategy meetings, bid-defense preparation meetings, bid defenses, capability presentations, and potential client engagement meetings as needed.
Review requests for proposals and proposals, and provide project estimates as needed.
Provide leadership for cross-functional and organization-wide initiatives where applicable.
Train and ensure all data management project team members are sufficiently trained.
Communicate with study sponsors, vendors, and project teams as needed about data, databases, and other relevant project issues.
Present software demonstrations and training, department or company training sessions, and project meetings as needed.
Perform other duties as assigned.

Desired Qualifications

Experience in a clinical, scientific, or healthcare discipline is preferred.
Experience with dictionary medical coding, including MedDRA and WHODrug, is preferred.
Understanding of CDISC standards, including CDASH, SDTM, and ADaM, is preferred.
Oncology and/or orphan drug therapeutic experience is preferred.

Position Summary:
The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.

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

Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
May perform quality control of data entry
Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
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. Oversee overall quality of the clinical database.
May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
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
Perform 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
Coordinate SAE/AE reconciliation
Liaises 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
Identify and troubleshoot 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
Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
May review Request for Proposals (RFP), proposals, provide project estimates
Provide leadership for cross-functional and organization-wide initiatives, where applicable
Trains and ensures that all data management project team members have been sufficiently trained
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:

10+ 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
Experience in utilizing various clinical database management systems
Broad knowledge of drug, device and/or biologic development and effective data management practices
Strong representational skills, ability to communicate effectively orally and in writing
Strong leadership and interpersonal skills
Ability to undertake occasional travel

Preferred:

Experience in a clinical, scientific or healthcare discipline
Dictionary medical coding (MedDRA and WHODrug)
Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
Oncology and/or Orphan Drug therapeutic experience

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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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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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