job title: Project support analyst(clario)

Roles and Responsibilities

What we offer

• Competitive compensation + shift allowances

• Attractive benefits (security, flexibility, support and well-being)

• Engaging employee programs

• Technology for hybrid working and great onsite facilities

What you'll be doing

The Project Support Analyst plays an important role in supporting clinical trials - completing actions related to study workflows and ensuring adherence to study-specific guidance and GxP standards. This role involves creating and managing events in the system, performing redaction and quality reviews of source data, facilitating translations, and initiating queries and performing other study-related tasks. Superior attention to detail and the ability to communicate clearly with team members are essential for achieving high-quality outcomes and maintaining project timelines. The Analyst must be able to quickly learn new tools and procedures and exhibit strong communication and problem-solving skills. Additionally, they ensure compliance with company SOPs and work instructions in the course of the performance of assigned duties.

The Project Support Analyst is generally tasked with actions related to the completion of events within study workflows during the active phases of clinical trial or study management, including but not limited to:

• Understand and adhere to study-specific guidance related to source document redaction and QC requirements; Understand and adhere to GxP related to source document processing.

• Provision customer user accounts within assigned studies/trials

• Perform and assist with the management and completion of events within the system such as Workflow Run creation, resumption, cancellation, completion and step assignment.

• Perform image, video or document quality review, redaction, and/or source preparation as specified by study-specific parameters and documented instructions, within required study timelines.

• Facilitate Source Document translation when required

• Create DICOM image links

• Become proficient in the use of provided tools (including but not limited to SightHound, PDF redaction tools, and others) to perform redaction of submitted source documents of various formats.

• Issue queries and perform routine follow-up with study sites for resolution, informing Clario Project and Operations managers of trends or issues jeopardizing study timelines.

• Assist with the generation and distribution of final study closeout deliverables

• Collaborate with cross-functional team members and authorities to ensure the specification and use of appropriate tools is identified and adhered-to. Attend project/team meetings as needed.

• Appropriately set and fulfill Clario Project Management and customer expectations related to completion of assigned tasks.

• Relentlessly pursue the highest quality output, professionalism, collaborative attitude and accountability to meet commitments.

• English fluency, in both written and verbal communication.

What we look for

• Associate/Bachelor’s Degree in life sciences, computer science, information technology or equivalent work experience

• 0-2 years in clinical trials, healthcare or a related field. 1 year or more of related clinical trial work experience preferred.

• Experience working with computer software including the MS Office suite (Word, Excel, Teams, OneNote).

• Ability to read documents in English and to identify deviations from Good Documentation Practice, specifically as it relates to identifying PII/PHI to be redacted from clinical trial source documents.

• Excellent attention to detail and meticulous work

• Ability to work both in a group setting and independently

• Ability to adjust to changing priorities and to handle difficult or stressful situations with professionalism, initiative and good judgement

• Ability to organize and prioritize assigned tasks to meet established schedules, timelines, or deadlines

• Excellent problem-solving abilities and dedication to quality work output

• Strong interpersonal and communication skills (both verbal and written)

• Ability to maintain a professional and positive attitude at all times