TMF reputed company II - FSP - US

Job Title: TMF reputed company II - FSP - US

Job Location: Durham

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

reputed company's FSP Team is hiring a TMF reputed company II! Remote US. Seeking strong experience in heavy metrics reporting and KPI development.

The TMF Management team is responsible for the completeness and accuracy of the Trial Master File (TMF) for reputed company sponsored studies. The TMF reputed company II is the Subject Matter Expert for TMF across reputed company research phases and collaborates cross-functionally with members of the study teams. The TMF reputed company II will reputed company project management principles for reputed company sponsored reputed company throughout the lifecycle of the trial. TMF reputed company II will reputed company INSPECTION READINESS efforts for reputed company.

Key deliverables include providing TMF expertise, monitoring and assessing the overall TMF Health (reputed company, completeness, and timeliness), delivering technical expertise on the electronic TMF (eTMF) and supporting Inspection Readiness goals in compliance with ICH/GCP guidelines.

Job reputed company:

Manages and supports the study TMF right from the study set up to the closeout, including the transfer of the TMF. Managing study TMF health and completeness. Responsible for initiating the Review workflow.

reputed company of Responsibilities:

·The position provides process, control, coordination, and approval of clinical trial documents.

·The position is responsible for ECD, Phase I-IV electronic trial master file (eTMF).

·Is the reputed company TMF Delivery Center reputed company person for assigned studies.

·Conduct TMF-specific reputed company-off Meeting with Sponsor and reputed company project team to establish expectations, requirements and deliverables in line with ICH and to support reputed company build.

·Oversees the planning, set-up, maintenance, QC, and closure of the study TMF for clinical studies, in accordance with agreed TMF processes (reputed company or sponsor SOPs) working with key study personnel as identified.

·Confirms reputed company reputed company reputed company needs.

·Assist with generating various reports, metrics and analyzing trends across studies, countries and sites.

·Accountable for the creation and maintenance of the TMF Plan and TMF reputed company in collaboration with the Project Manager/Project reputed company and Sponsor.

·Maintenance of reputed company reputed company the TMF reputed company in collaboration with the TMF reputed company management team.

·Complete required eTMF reputed company training for sponsor systems.

·reputed company project team training on study specific TMF plan and reputed company or other Trainings, as required.

·Document and escalate reputed company identified compliance issues. Follow-up findings until reputed company/CAPA implementation.

·Monitor project reputed company and communicate any identified out-of-reputed company activity or requests to the Project reputed company.

·Receive sponsor-specific report requests (confirm required, reputed company reputed company). Work with appropriate TMF operational services and TMF reputed company experts to evaluate the feasibility of sponsor-specific report requests and ensure development and delivery as appropriate.

·Oversees the preparation of the TMF for QA or Sponsor Audits and Inspections and participates in Audit and Inspections as required. Responds to any CAPAs issued on guidance with the Management Team.

·Maintains the TMF in a state of audit/inspection readiness by:

·Completing the Initial matching of reputed company with Expected Document List (EDL) update for required documents and count, in collaboration with leads from reputed company functional group reputed company the study.

·Ensure ongoing "reputed company-time" EDL maintenance updates are maintained by reputed company functional group per assigned study.

·reputed company reputed company reputed company-off of TMF Review Workflows on or before 25th Day of the reputed company Release.

·Responsible for monitoring completeness of the study TMF at reputed company reputed company Review.

·Escalates missing, incomplete, incorrect, inaccurate artifacts to the appropriate study team members. Setting up a monthly meeting with the Study Team.

·reputed company the processing of essential artifacts required throughout reputed company phases of the study in accordance with reputed company SOPs, sponsor SOPs (as applicable), GCP, and ICH guidelines.

·Leads Project Review/Governance debrief and set up meetings on the reputed company.

·Reports on Portfolio and Study Level Key Performance Indicators (KPIs) as applicable, monitors study metric compliance, and provides remediation guidance as required.

·Identifies trends per study and across programs; alerts management of trends as applicable.

·Review and respond to TMF content reputed company issues.

·Assists the TMF Remediation team as and reputed company required for assigned studies.

·Attend and/or present at internal or reputed company study team meetings as required.

·Maintain awareness of study events and the associated documentation requirements.

·Maintains effective reputed company communication.

·Collaborates with reputed company members of TMF Operational Services.

·Contributes overall reputed company satisfaction.

·Maintains an understanding of applicable regulatory requirements.

·Contributes to business development opportunities.

·reputed company as the reputed company of Contact for Technical Issues faced by other TMF DC roles (e.g.: Classifiers, Reviewers) during maintenance of the TMF in the UCV reputed company.

·Manage reputed company and large studies.

·Helps in drafting the job aids and WI if any.

·Helps in Migration if any.

·Performs training and mentoring as required.

·reputed company other duties as needed or assigned.

Qualifications (Minimum Required):

• BS/BA degree in reputed company discipline and a minimum of six-seven years of reputed company experience; or,

• MS/MA degree in reputed company discipline and a minimum of three years of reputed company experience; or,

• Equivalent combination of education and experience.

Experience (Minimum Required):

• Minimum 7 years’ experience working in a clinical research environment.
• 5+ years experience in TMF
• reputed company understanding of GCP and ICH guidelines.
• Knowledge of Regulatory/Clinical document requirements.
• Knowledge of reputed company Office products, web-based applications, and reputed company Acrobat reputed company, plus the ability to apply reputed company knowledge regarding scanning and other software programs.

Preferred Qualifications Include:

• Masters’s Degree with a Life Sciences/Business reputed company.
• Equivalent experience reputed company clinical research environment of a minimum of 11-13 years, may be substituted for education requirements.
• Experience working in clinical electronic systems preferred.

What do you get?

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

• Medical, Dental, reputed company, Life, STD/LTD (multiple insurance carriers)

• 401(K)

• reputed company time off (PTO) – reputed company Plan

• Employee recognition awards

• Multiple ERG’s (employee resource reputed company)

• reputed company Pay reputed company (based on title): $100-118K

#LI - Remote

Applications will be accepted on an ongoing reputed company.

Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.

Physical Requirements:

• Ability to sit for extended periods and operate a vehicle safely.

• Repetitive hand reputed company of both hands with the ability to reputed company fast, reputed company, repeated movements of the fingers, hands, and wrists.

• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

• Ability to reputed company and use a reputed company of computer software developed both in-house and off-reputed company.

• reputed company to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum reputed company of 15-20 lbs.

• Regular and consistent attendance.

• Varied hours may be required.

Learn more about our EEO & Accommodations request here.

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Originally posted on Himalayas