850 Clinical Informatics jobs in India

Department/Unit:

Work Shift:

Salary Range:

Computer System Design, Implementation, & Evaluation:

-Designs and supports systems and manages projects directed at improving quality and patient care outcomes using information technology.

- Maintains current knowledge of computer applications used within the organization, evolving technologies, and current patient safety literature to guide system modifications and the pursuit of new clinical technology.

-Conducts periodic workflow analysis to optimize the use of technology in patient care. Provides input or clinical functions that are suitable for computer application and ensures the information systems are consistent with professional standards of clinical practice.

-Collaborates with the end user throughout the organization on all computer system related initiatives.

-Co-lead and coordinate user group forums to continuously evaluate and improve system functionality.

-Collaborates with Director of Informatics, CNIO, CHIO, CMIO, CNO, Nursing Directores, AVPs and managers, Technology and IT staff on special projects.

-Coordinates the design and promotion of useful ,innovative information technologies that advance practice interoperability and achieve desired outcomes.

-Considers the impact of technological changes on patient safety, healthcare delivery, quality reporting, and clinical process.

-Participates in organizational level and campus committees and work groups to advance technology and patient care

Staff Education:

-Collaborates with Education department(s) staff to design documentation tools and technology interfaces that foster safe and efficient care, and satisfy regulatory and accreditation requirements.

-Communicates initiatives and enhancements for Patient Services, organizationally.

Quality and Performance Improvement:

-Identifies and supports system changes to support improvements in patient care and enhanced workflow and productivity.

-Incorporates key ethical concerns such as advocacy, privacy, and assurance of the confidentiality and security of data and information.

-Supports decision making of consumers, nurses, and other professionals to achieve and safety and advocacy.

Qualifications:

-Bachelor’s degree in health, business, or informatics field, required.

-Master’s degree in health, business, or informatics field, preferred.

-Minimum six years experience in a health care setting.

-Minimum three years experience in clinical informatics.

-Epic Clinical Informatics Certification upon hire.

Thank you for your interest in Albany Medical Center!

Albany Medical is an equal opportunity employer.

This role may require access to information considered sensitive to Albany Medical Center, its patients, affiliates, and partners, including but not limited to HIPAA Protected Health Information and other information regulated by Federal and New York State statutes. Workforce members are expected to ensure that:

Access to information is based on a “need to know” and is the minimum necessary to properly perform assigned duties. Use or disclosure shall not exceed the minimum amount of information needed to accomplish an intended purpose. Reasonable efforts, consistent with Albany Med Center policies and standards, shall be made to ensure that information is adequately protected from unauthorized access and modification.

Role : Associate Manager - Clinical Data Management

Location : Chennai, Tamil Nadu

Experience : 10+ Years

Requirements:

• 10-12 years of experience in clinical trial/data management and data operations.
• Minimum 4-5 years of people management (preferred) experience with proven supervisory
• skills.
• Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS, or similar).
• Strong background in EDC systems management and clinical data operations.
• Experience in pharmaceutical, biotechnology, or CRO environment across multiple
• therapeutic areas.

Technical Expertise

• CTMS configuration and administration skills (Having knowledge in CRIO is an advantage).
• Deep knowledge of EDC platforms and system integrations.
• Strong understanding of regulatory requirements (HIPPA, FDA, EMA, ICH-GCP).
• Experience with electronic systems validation and 21 CFR Part 11 compliance.

Key Accountabilities

* Under the direction of the CDM Lead or delegate, performs data management tasks according to applicable SOPs (standard operating procedures) and processes. These activities may include the following categories:

Data Review

* Performs data review of clinical trial data, including query management

* Performs reconciliation review of external data against EDC data

* May assist in creating study documents or assist in running study reports and metrics

* Performs additional review activities for interim and final database locks as needed.

Documentation & Filing

* Files study documentation in electronic Trial Master File (eTMF) and department project files.

* Performs periodic quality review of eTMF documents.

* Assists with taking meeting minutes and documenting/tracking study data management activities.

* Performs data archival activities.

* Performs inspection readiness activities and supports CDM team during internal and regulatory inspections

Data Collection Systems

* May support the set-up and testing of study data collection tools.

Additional Activities

* Assists with quality review of above activities performed by the CRO, as needed.

* Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.

* Performs other duties as assigned.

Educational Qualifications

* Associate or Bachelor's Degree preferred

Experience

* Ideally 1 or more years relevant work experience, or equivalent combination of training and experience.

* Familiar with electronic data collection systems

* Preferred knowledge of data management best practices & technologies as applied to clinical trials.

* Preferred knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.

Special Skills/Abilities

* Strong attention to detail, and organizational skills

* Good time management skills

* Quick learner and comfortable learning new technologies and systems

* Good knowledge of office software (Microsoft Office).

Behavioral Competencies

* Is comfortable with ambiguity.

* Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.

Role: Clinical Data specialist

Skill: CDM, Rave

Mode: Hybrid

Experience: 2-5 years in Clinical Data management

Job Location: Kochi/Kolkata/Bangalore

Educational Qualification: Any life science graduate

Job Overview:

Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.

Essential Functions

• Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance.
• May serve in the role of back-up to a DOC or DTL.
• May conduct data review.
• May write and resolve data clarifications.
• May lead database audit team.
• May develop and test databases and edit specifications.
• May perform testing of programming.
• May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team."

Qualifications

• Bachelor's Degree Clinical, biological , or related field Req
• Equivalent combination of education, training and experience in lieu of degree.

Role: Clinical Data specialist

Skill: CDM, Rave

Mode: Hybrid

Experience: 2-5 years in Clinical Data management

Job Location: Kochi/Kolkata

Educational Qualification: Any life science graduate

Job Overview:

Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.

Essential Functions

• Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance.
• May serve in the role of back-up to a DOC or DTL.
• May conduct data review.
• May write and resolve data clarifications.
• May lead database audit team.
• May develop and test databases and edit specifications.
• May perform testing of programming.
• May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team."

Qualifications

• Bachelor's Degree Clinical, biological , or related field Req
• Equivalent combination of education, training and experience in lieu of degree.

Experience: 5+ yrs

Work Mode: Work from Office

Work Location: Bangalore

LOOKING FOR IMMEDIATE JOINERS ONLY

Job Description - Clinical Data Manager :

OVERVIEW

The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science.

KEY TASKS & RESPONSIBILITIES

• Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.

• Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.

• Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.

• Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issue, risks and develop mitigation strategies.

• Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data.

• Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager.

• Perform Query Management

• Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate® Data Central for data cleaning strategy and oversight activities.

• Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.

• Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate® Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness.

• Collaborate and work as a team to ensure the deliverables are completed on time with high quality.

• Ensure compliance with industry quality standards, regulations, guidelines, and procedures.

• Other duties as assigned.

CANDIDATE’S PROFILE:

Education & Experience

• 5+ years’ experience in Clinical Data Management preferred.

• Bachelor’s degree in a health-related field or equivalent experience preferred.

• CCDM Certification preferred.

Professional Skills

• Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems.

• Strong analytical and strategic thinking skills

• Detail oriented, ability to multitask with strong prioritization, planning and organization skills.

• Excellent collaborative skills

• Demonstrated command of the English language with proficiency in both verbal and written communication

Technical Skills

• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel

• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology

• Proficient with EDC and Clinical Data Management Systems

• Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred.

• Experience with RBQM methodology preferred.

• Exposure to CDISC guidelines and standards