Senior Essential Document Specialist

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Senior Essential Document Specialist to join one of our partner companies, a large pharmaceutical company in USA. This is a permanent, remote role.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Main Job Tasks and Responsibilities:

• Support Essential Document Leads and Manager.

• Support strategies, procedures, and tools for the optimization of the processes.

• Applies creative solutions to complex site ready situations and demonstrates situational leadership within cross functional teams.

• Recognizes and considers various solutions to problems or situations.

• Works with internal/external partners to assure document processing times are maintained.

• Monitors/tracks compliance of study essential documents.

• Ensures the integrity of the essential clinical trial documents (both hardcopy and electronic) within the Official Regulatory files.

• Ensures proper communication with external partners, stakeholders, and customers.

• Liaises with clinical teams and external partners to achieve site ready timelines.

• Interfaces with staff members to provide support and guidance.

• Provide monthly/bi-monthly report on the Trial Master File Status for a study to ensure that the electronic Trial Master File is always Inspection Ready.

• Responsible for creation and monthly maintenance of study Trial Master File Plans.

• Assist with the Archival process to ensure all resolvable items have been addressed prior to final archival of a study.

• Trial Master File review and reconciliation of study and site files to ensure completeness.

• Essential Document review of the Trial Master File Plan.

• Assist with the onboarding of new employees.

• Identifies and reviews metrics to assure process remains efficient and effective.

• Works with inspection support teams to ensure inspection process readiness.

• Assists in retrieval of documentation during sponsor inspections.

• Supports the development of responses to audits and inspections and ensures appropriate implementation.

• Ensures that all actions and commitments are implemented in a timely manner.

Education and Experience:

• High School Diploma required; Bachelor’s degree preferred

• A minimum of 3 years as an Essential Document Specialist and at least 5 years of relevant experience in clinical research.

• General knowledge of ICH-GCP and other relevant regulations pertaining to essential documents.

• Must have intermediate understanding of the functional area responsibilities associated with the clinical development process, trial management, and clinical trial management systems, as well as quality management and control tools.

Specific Role Requirements and Skills:

• Strong verbal, written and organizational skills with a team-oriented approach as well as works well independently

• Strong time management skills

• Detail oriented

• Self-motivated

• Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment.

• Demonstrated ability to manage multiple projects with varying deadlines is also required, support cross-functional teams of business professionals, analyze, interpret, and propose solutions to complex problems.

• Working knowledge of electronic Trial Master File is required.

• Intermediate level in Adobe Acrobat including knowing how to edit, extract and redact pages

• Microsoft Office Suite 2010 or higher: Beginner to Intermediate experience level in WORD; Intermediate experience level in EXCEL; Intermediate experience level in Outlook.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.       

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Senior Essential Document Specialist, clinical Trial Management, ICH-GCP, TMF, eTMF, Microsoft Office, CRO, Contract Research Organization, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-LG1 #LI-REMOTE #PERMANENT