Clinical Studies Specialist II

This position operates in a highly regulated environment and requires excellent organizational and time management skills, strong written and verbal communication skills, and the ability to follow detailed instructions and established processes. Job Description: This contractor position supports the creation, transfer, review, and coordination of clinical labels for clinical supplies used in clinical studies.

What are the top 3-5 skills, experience or education required for this position:
1. Strong attention to detail and accuracy
2. Proficiency with computers and ability to quickly learn new systems
3. Data entry and document review experience
4. Strong organizational, time management, and prioritization skills
5. High school diploma or equivalent; BA/BS degree preferred in Science, English, Business or related field

Suggested Title: Clinical Labeling Support Specialist

Job Description:
This contractor position supports the creation, transfer, review, and coordination of clinical labels for clinical supplies used in clinical studies. The role requires exceptional attention to detail, strong computer proficiency, and the ability to quickly learn and apply new systems and processes. A high degree of accuracy in data entry and document handling is essential.

This position operates in a highly regulated environment and requires excellent organizational and time management skills, strong written and verbal communication skills, and the ability to follow detailed instructions and established processes. The successful candidate must be dependable, self-motivated, able to work independently, and also function effectively as part of a team. The ability to adjust priorities on short notice in response to changing business needs is critical.

Key Responsibilities
Transfer clinical labels into a new system
Create and design clinical labels according to established requirements
Proofread label proofs to ensure accuracy and compliance
Coordinate labeling documentation and related approvals
Support additional labeling-related projects as needed
Additional Responsibilities, if the Contractor Proves Successful
Manage assigned labels and studies independently
Create labels using source documents and global regulatory requirements, ensuring information is complete, consistent, and accurate
Communicate and coordinate labeling and documentation activities with worldwide affiliates
Maintain professional communication with internal business partners and global stakeholders

Qualifications
Proficient computer skills and ability to quickly learn new software and systems
Data entry experience with a high degree of accuracy
Strong attention to detail and organizational skills
Excellent written and verbal communication skills
Ability to work independently with minimal supervision
Ability to collaborate effectively as part of a team
Strong time management skills and ability to manage multiple priorities
Comfortable working in a highly regulated environment
Able to follow detailed instructions and established procedures
Flexible and responsive to changing priorities and business needs