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Galderma · 1 day ago

Clinical Trial Assistant

Boston, MA

Full-time

Onsite

Entry, Mid Level

3+ years exp

Galderma is an emerging pure-play dermatology category leader, present in approximately 90 countries. The Clinical Trial Assistant is responsible for performing a variety of research, database, and clerical duties in support of multiple clinical trials, providing administrative support to clinical teams and ensuring compliance with federal regulations.

Pharmaceuticals

Responsibilities

Overall responsibility of Trial Master File (TMF): set up, maintenance and archiving for in-sourced or outsourced studies

For out-sourced studies, controls administrative work ensuring CRO maintains a complete trial master file and organized shipment to Galderma in the appropriate format at the end of the study

For in-sourced studies, assures filing on an ongoing basis of a complete TMF (including insurance, translations, approvals, etc.)Completes TMF Quality Control and subsequent Quality Assurance audit resolution including drug reconciliation documentation in collaboration with Clinical Team

Assures administrative archiving of the TMFEnsures consistency and set up between all outsourced studies to our TMF structure

Assist in study set-up activities (regulatory binders, investigator meetings, presentations, CDAs, agreements, insurance, etc.)

Serve as the contact and/or liaison for the CRO and Investigative sites for regulatory documents, clinical supplies, CRFs, study agreement (financial contract), and other pertinent administrative matters, under the supervision of the CPM or delegated CRA

Process invoices and Investigator payments after appropriate approval obtained by Clinical Project Manager

Assemble final report appendices; ensure final report completeness in collaboration with Clinical team

Work on a Global Project Team and interface with Europe and Global counterparts, as needed

Responsible for set up of public registries and maintenance

Other duties as assigned

Qualification

Clinical Trial Assistant experienceFDA GCP-ICH GuidelinesBachelor’s DegreeClinical administrative experienceProactiveCommunication skillsInterpersonal skillsOrganizational skillsTeamworkSelf-motivated

Required

Bachelor's Degree in a related field, or equivalent combination of training, education and work experience, required

Three (3) or more years of experience in a clinical administrative or regulatory role in a pharmaceutical or CRO environment

One or more years of experience in a Clinical Trial Assistant role

Previous administrative work experience, preferably in an international clinical research setting

Knowledge of FDA GCP-ICH Guidelines and local regulatory requirements

Ability to demonstrate a high level of competency relating to administrative and clerical responsibilities, procedures, and systems

Ability to handle confidential information and materials in an appropriate manner, and in accordance to organizational policy, proper business practice, and/or appropriate external regulation/governance

Ability to work within a team environment and to clearly communicate with others (internal and external customers)

Excellent communication (verbal/written), interpersonal, and organizational/ time management skills

Self-motivated, quick to learn, proactive and flexible