Senior Associate, TMF Operations

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

SUMMARY: The Senior Associate, TMF Operations is responsible for the processing, maintaining and archiving of all essential documents in compliance with the relevant Standard Operating Procedures, country regulations and industry best practice. The Senior Associate will support the delivery of department objectives in ensuring the management essential documents. This is a global role and will require working with Worldwide Project Team members and Quality Assurance.

RESPONSIBILITIES:

• Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant Standard Operation Procedure(s) (SOP)
• Deputize for "TMF Process Owner" where necessary
• Process Trial Master File (TMF) documents for multiple studies both in an electronic and hard copy format
• Prepare periodic TMF Quality Control checklists for review by Project Team review
• Maintenance of TMF metrics and spreadsheets for assigned studies
• Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices
• Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents
• Communicate directly with multiple Project Team members to assess project needs relevant to the TMF
• Escalate any TMF Quality issues in a timelines manner to relevant parties
• Act as a mentor to junior members of the team
• Prepare and transmit TMF and other critical documents to the Sponsor in accordance with the relevant instructions
• Support Regulatory and Sponsor audits, where necessary

OTHER SKILLS AND ABILITIES:

• Possess data collection, indexing and editing skills, including ability to adhere to standardized
• document naming conventions
• Possess excellent written and verbal communication skills to clearly and concisely present
• information
• Work independently and with teams and can execute tasks works under general direction, seeks assistance as needed
• Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing
• environment
• Exercise sound judgment and ability to identify decisions requiring supervisory approval
• Handle multiple, highly detailed tasks with exceptional accuracy
• Develops solutions to technical problems of moderate complexity
• Deliver advise to Project Team members on key TMF issues
• Demonstrate strong planning and organizational skills
• Demonstrate proficiency in Microsoft Word and Excel
• Develop proficiency in use of an electronic document repository
• Understanding and adherence to corresponding Worldwide and sponsor standard operating
• procedures
• General understanding of clinical research principles and processes

REQUIREMENTS:

• University Degreed preferred ( Life Science desirable )
• Combination of education plus 2-5 years of relevant experience
• Knowledge of working within a highly regulated industry (desirable) or experience of CRO/Pharmaceutical Company industry

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