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Sr. Clinical Trial Coordinator - eTMF

EXTRA HOLIDAYS - EXTRA PARENTAL LEAVE

Remote:

Full Remote

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

India

Offer summary

Qualifications:

Bachelor's degree preferred, 4-6 years of relevant experience, Strong knowledge of Clinical Trials, Experience with eTMF, CTMS systems, Excellent English and local language skills.

Key responsabilities:

Provide administrative and technical support to the Project Team
Coordinate project activities as a cross-functional liaison
Ensure timely task performance within budget and quality standards
Maintain and analyze study-specific documentation and metrics
Support scheduling and organization of meetings

Thermo Fisher Scientific Biotech: Biology + Technology Large https://www.thermofisher.com/

10001 Employees

HQ: Waltham

See more Thermo Fisher Scientific offers

Job description

Your missions

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Summarized Purpose:

Provides administrative and technical support to the Project Team. Coordinates and facilitates project activities and may serve as a study lead acting as a cross-functional liason for the project team. Acts as a buddy during onboarding phase and provides training to new staff as needed. Supports departmental and cross-functional initiatives for process improvements/enhancements.

Essential Functions and Other Job Information:

According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clienst, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.
Provides system support (i.e. GoBalto & eTMF).
Supports RBM activities.
Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
Reviews and tracks local regulatory documents.
Transmits documents to client and centralized IRB/IEC.
Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
Maintains vendor trackers.
Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Assists with study-specific translation materials and translation QC upon request.
May attend Kick off meeting and take notes when required.

Education and Experience:

Bachelor's degree preferred.
4-6 years of previous experience that provides the knowledge, skills, and abilities to perform the job

Knowledge, Skills and Abilities:

4-5 Years of experience and strong knowledge of Clinical Trials, experience with eTMF (preferably Veeva, other experiences can be considered), CTMS, Essential Documents, ICH GCP Guidelines.
Must have very good Business communication skills
Ability to work in a team or independently as required
Strong organizational skills and attention to detail, with proven ability to handle multiple tasks
efficiently and effectively
Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
Strong customer focus
Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet
changing project timelines
Demonstrated ability to attain and maintain a good working knowledge of applicable Country
Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all nonclinical/
clinical aspects of project implementation, execution and closeout
Excellent English language and grammar skills and proficient local language skills as needed
Good presentation skills
Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain
knowledge and master all clinical trial database systems
Ability to successfully complete PPD clinical training program
Self-motivated, positive attitude with effective strong interpersonal skills