Associate Director, Global Clinical Trial Management
Associate Director, Global Clinical Trial Management
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Job Description
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.
Title: Associate Director Global Clinical Project Management
Location: Boston
Position Summary:
The Associate Director Global Clinical Trial Management oversees the Clinical Trial Managers working on the clinical studies globally to ensure overall programs are executed according to timelines budget and meeting quality standards. This position ensures compliance with SOPs Regulatory requirements and ICH/GCP guidelines and aligns with company strategies and goals.
Responsibilities:
- Oversees operational aspects of trial set-up execution oversight and reporting for clinical studies while ensuring the trials are conducted in compliance with the protocol ICH/GCP and applicable regulatory requirements.
- Proactively identifies potential study issues/risks and recommends/implements solutions with the Clinical Project/Trial Managers.
- Provide expertise to the Clinical Project/Trial Managers across all indications and locations and serve as a mentor to the CPM/CTMs.
- Participates in protocol CRF development and Clinical Study Report preparation as appropriate.
- Develops/prepares metrics and updates for management.
- Participates in CRO oversight of Clinical Operations functional activities (eg study management monitoring site management trial master files).
- Work with CRO to ensure that performance expectations are met across programs.
- Recommends and implements innovative process ideas to impact effective and efficient clinical trials management.
- Recognizes cross functional or company-wide impact of problems and considers implications in solution management while serving as an escalation point and resource for internal and external teams to help drive strategy and study initiatives.
- Establishes partnership with Global Medical Affairs (GMA) on clinical trials implementation and process as liaison between GMA and Clinical Operations.
- Develop and organize the business in collaboration with the other managers within Global Clinical Operations.
- Participates in the development review and implementation of departmental SOPs and processes.
- Participate in financial meetings on budget of clinical trials.
- May be assigned other projects and duties as required
- May serve as a CPM/CTM on various studies
- Manage contractors working on clinical studies.
Requirements
- Bachelors degree preferably in a biologic/scientific discipline is required.
- 8 years in pharmaceutical clinical drug or device development with experience in global clinical trials and program execution.
- Systemic route of administration clinical trials experience required; pediatric drug/device combination device device and/or biologics experience preferred.
- Thorough understanding of country-level regulations ICH and GCP guidelines cross-functional clinical processes including data management biostatistics medical writing drug safety and regulatory affairs.
- Vendor management experience preferred.
Physical Requirements:
The work environment characteristics and physical requirements described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing duties of this job the employee may or may not be frequently/or occasionally required to:
- Stand; walk; sit; climb or balance; stoop; kneel; crouch; talk or hear; and taste or smell.
- Climb stairs or ride elevators.
- Lift and/or move up to 25 pounds.
- Use close vision distance vision peripheral vision depth perception and ability to adjust focus.
- Manipulate keyboard or otherwise access computer telephone and hand-held devices.
- Be exposed to outside weather conditions while going in and out of office buildings.
- Be exposed to moderate noise level usually in warehouse settings.
- Be exposed to moving equipment mechanical parts and/or high places; or moving between air-conditioned and non-air-conditioned environments.
- Travel is required less than 25%
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 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.
Required Experience:
Exec
Employment Type
Full-Time
