Clinical Trial Assistant

Galderma is the emerging pure-play dermatology category leader present in approximately 90 countries. We deliver an innovative science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981 we have dedicated our focus and passion to the human bodys largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives we are advancing dermatology for every skin story.

We look for people who focus on getting results embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all they must be passionate about doing something meaningful for consumers patients and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company we embrace diversity and respect the dignity privacy and personal rights of every employee.

At Galderma we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled direct impact.

Job Title: Clinical Trial Administrator

Location: Boston

Job Description

The CTA (Clinical Trial Assistant) is an experienced level or associate level (junior level) position responsible for performing a variety of research data base and clerical duties of a complex and technical nature in support of multiple clinical trials. This position also provides administrative support to clinical teams by reviewing vendor invoices for accuracy against budget tracking vendor payments in compliance with federal regulations and taking meeting minutes during project team meetings.

Key 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

Preferred Skills and Qualifications

• Bachelors 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

What We Offer in Return

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

Next Steps

• If your profile is a match we will invite you for a first virtual conversation with the recruiter.
• The next step is a virtual conversation with the hiring manager
• The final step is a panel conversation with the extended team

Our people make a difference

At Galderma youll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism collaboration and a friendly supportive ethos is the perfect environment for people to thrive and excel in what they do

Employers Rights:

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract and either you or the employer may terminate employment at any time for any addition reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.