Senior Officer

2+ years

Not Disclosed

Ahmedabad

10 Dec. 19, 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: Quality System Management Support – Clinical Imaging Services
Location: [Location not specified]
Company: [Company Name not specified]

Organizational Overview:
The organization is a leading player in clinical research, specializing in providing quality system management assistance to investigational products. We focus on ensuring compliance with regulations such as 21 CFR Part 312, 21 CFR Part 211, ICH E6, and ISO standards. Our services include supporting training programs, managing nonconformance (deviation and CAPA programs), and providing direct QA support. We also conduct clinical trial data entry, quality control reviews, and various data/image transfer and quality checks.

Job Details:
This role requires a candidate to support quality system management within the clinical trial process, ensuring compliance with regulatory standards. Key responsibilities include providing direct support for training programs, deviation management, and CAPA programs, along with reviewing and entering clinical trial data into systems. The role also involves conducting data reviews of CRFs, eCRFs, reports, or data listings, generating queries, and performing post-reader quality checks as applicable.

Key Deliverables:

Assist in the creation, editing, and review of documentation for procedures related to operations and quality management systems (QMS).
Enter clinical trial data into data collection tools and conduct quality control reviews of the data.
Generate, track, and close queries for images, reports, CRFs, eCRFs, as applicable.
Conduct data/image transfers and perform post-reader quality checks as necessary.

Allied Responsibilities:

Ensure compliance with all relevant procedures, rules, and regulations related to clinical trial data and quality systems.
Maintain confidentiality of sensitive data, records, and conversations.
Collaborate with team members and management to manage nonconformance and CAPA programs effectively.

Experience:

Minimum of 2 years of experience in Clinical Imaging Services.
Strong attention to detail with excellent oral and written communication skills.
Ability to work in a team environment and excel under pressure.
Strong organizational and time management skills with the ability to multitask and prioritize.
Ability to assess the importance of communications and take prompt and accurate actions.
Experience in working precisely according to regulations and maintaining confidentiality.

Skills and Experience:

A minimum of 5 years of experience in clinical trials.
Bachelor’s degree or relevant experience preferred.
Competence in data entry and working with medical terminology.
Working knowledge of clinical trials and the healthcare industry is required.
Proficiency in MS Office and internet applications.

Competencies:

Accountability and communication skills.
Strong work ethic, initiative, and leadership abilities.
Flexibility, planning, and organizational skills.
Motivation, interpersonal skills, and the ability to make presentations effectively.
Academic qualifications and technical knowledge in clinical trials.

Why Join Us?
This role is an exciting opportunity for professionals with a passion for quality management in clinical trials. If you’re motivated, organized, and have a strong background in clinical data management and quality assurance, you will thrive in our dynamic and supportive environment.

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