Senior Officer

2+ years

Preferred by Comapny

Ahmedabad

12 Nov. 24, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Officer

Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
Department: Quality Assurance / Clinical Imaging Services

About Lambda Therapeutic Research Ltd.

Lambda Therapeutic Research Ltd. is a globally recognized Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with operations spanning across the USA, UK, and Poland. With over two decades of experience, Lambda offers comprehensive clinical trial solutions and is committed to driving innovation and maintaining excellence in clinical research.

Position Overview

The Senior Officer will assist in the management of quality systems, ensuring compliance with regulatory standards for investigational products, including 21 CFR Part 312, 21 CFR Part 211, ICH E6, and ISO standards. The role involves direct quality assurance (QA) support, nonconformance management, data quality review, and clinical imaging services, contributing to the overall integrity of clinical trials.

Key Responsibilities

Quality Assurance & Documentation

Provide QA support for training programs and nonconformance management, including deviation and CAPA programs.
Create, edit, and review documentation for operations and Quality Management Systems (QMS).
Ensure compliance with regulatory and procedural standards for clinical trials.

Clinical Trial Data Management

Enter clinical trial data into data collection tools.
Conduct quality control reviews of clinical trial data and related documentation.
Perform data reviews for Case Report Forms (CRFs), electronic CRFs (eCRFs), reports, and data listings.
Generate, track, and close queries related to images, reports, CRFs, and eCRFs.

Data/Image Transfers & Quality Checks

Conduct data and image transfers as applicable.
Perform post-reader quality checks and ensure compliance with imaging services standards.

Experience & Skills Required

Experience

Minimum 2 years of experience in clinical imaging services.
5 years of experience in clinical trials or related fields preferred.

Educational Qualifications

Bachelor’s degree or relevant experience required.
Working knowledge of medical terminology and clinical trials is preferred.

Key Skills

Strong attention to detail and time management skills.
Excellent oral and written communication.
Ability to multitask, prioritize, and work under pressure.
Proficiency in MS Office and internet applications.
Familiarity with clinical data entry and documentation processes.
Knowledge of healthcare or clinical trials industry is essential.

Competencies

Accountability: Deliver results with accuracy and timeliness.
Communication: Maintain clear and professional communication.
Work Ethic: Demonstrate dedication and integrity.
Leadership: Provide guidance and lead by example.
Flexibility: Adapt to dynamic project needs and timelines.
Organizational Skills: Prioritize and organize tasks effectively.

Why Join Lambda?

Lambda values innovation, precision, and teamwork. Employees are encouraged to grow professionally in a supportive and challenging environment that prioritizes quality and regulatory excellence.

Become a part of our mission to drive breakthroughs in clinical research and contribute to global healthcare innovation.

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