Senior Clinical Trial Manager - Boston

Galderma; Boston (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

A leading company in dermatology seeks a Senior Clinical Trial Manager in Boston. The role involves planning and managing global clinical trials, ensuring compliance with regulations, and leading cross-functional teams. Candidates should have extensive experience in clinical research and a relevant degree in Life Sciences. The company values diversity and offers competitive benefits.

Benefits

Competitive wage with shift differential

Annual bonus opportunities

Career advancement

Cross-training

Qualifications

• Progressive experience in clinical research/operations (≥15 years).
• 5 years in a managerial role or equivalent with Pharma/Biotech/CRO experience.

Responsibilities

• Plan and conduct clinical trials, managing timelines and budgets.
• Lead cross-functional Clinical Trial Team to meet deliverables.
• Ensure compliance with regulatory requirements and quality standards.

Skills

Leadership

Risk Management

Collaboration

Education

University degree in Life Sciences

Job description

Join to apply for the Senior Clinical Trial Manager - Boston role at Galderma

Join to apply for the Senior Clinical Trial Manager - Boston role at Galderma

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At Galderma we're unique and we embrace difference.

Whether it's the unique breadth of our integrated offering that covers Aesthetics, Consumer, and Prescription products; or our commitment to recognising and rewarding people for the contribution they make - working here isn't like anywhere else.

At Galderma, we actively give our teams reasons to believe in our 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.

Based in our Boston office, the Senior Clinical Trial Manager (CTM) plans and manages overall activities for assigned global clinical trial(s). This includes timelines, budgets, resources, investigational sites, vendors and key deliverables. This position ensures compliance with SOPs, regulatory requirements and ICH/GCP guidelines and aligns with company strategies and goals. The Senior CTM may lead other CTMs in the organization depending on the scope of the clinical trial.

Key Responsibilities:

Plan and Conduct Clinical Trials

Lead and manage cross-functional Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices.

Work closely with the Clinical Science Experts and Clinical Scientist for the design of the clinical trials.

Establish project milestones, budget and timelines for the study in partnership with the Clinical Trial Team and outsourcing manager.

Manage clinical trial progress and ensure completeness of documentation and data collection in adherence with the project timelines.

Proactively identify potential risks and develop & implement action plans to avoid or mitigate program risks.

Contribute to the reporting of clinical studies and clinical documentation to regulatory submissions according to plan and in compliance with applicable regulatory requirements, international standards and the company quality system throughout the development life cycle

As applicable, provide oversight to Clinical Research Associates and Clinical Trial Administrators assigned to the clinical trial

Manage Contract Research Organizations (CROs) and Functional Service Providers (FSPs)

Collaborate with Procurement to prepare clinical outsourcing specifications.

Participate in the selection of the CRO or FSPs.

Serve as the primary trial contact with the CRO and FSPs.

Quality and Process

Ensure that all aspects of the trial are prepared for regulatory inspections at any time.

Serve as member of the inspection readiness team in preparation of a regulatory inspection.

Support the preparation for and conduct of investigational site and sponsor health authority inspections, as applicable.

Contribute to and initiate trial and departmental process improvement initiatives.

Key Qualifications:

University degree required in Life Sciences such as biology, pharmacology, nursing, or health sciences

Progressive experience in clinical research/operations (≥15 years), including 5 years in a managerial role or equivalent with Pharma/Biotech and/or CRO experience

Experience from all parts of the clinical trial process, from protocol development to the compilation of study reports

Experience as manager of clinical trials in major market(s) such as US, China

Experience in supervising CROs

Excellent understanding of the drug development process, systemic drug and biologics experience preferred

Excellent knowledge of international ICH/GCP guidelines, basic knowledge of GMP/GDP

Excellent knowledge of relevant local regulations

Fluent in English (written and oral)

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. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.

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, you'll 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.

Employer's 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 reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Consumer Services

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