Clinical Trial Manager
The Clinical Trials Manager is responsible for the day-to-day activities associated with managing clinical studies. Working closely with the Associate Director, Clinical Operations and collaborating with colleagues in other functions, the Clinical Trials Manager supports the operational team to ensure excellent operational oversight of clinical studies. The Clinical Trials Manager contributes to and manages the project plans, manages and oversight of vendors, performs tasks during protocol design to final CSR, to produce high-quality study data, adherence to Good Clinical Practice and to achieve corporate goals on time and on budget.
Roles and Responsibilities
1. Manages clinical studies, including vendor management and oversight including CROs, IRB, DSMB and CRAs as needed.
2. Organize and participate in investigational meetings and site training.
3. Coach and mentor all staff under him/her; set objectives, solicit 360° feedback from stakeholders and conduct performance reviews to foster growth of staff.
4. Ensure all necessary training is provided to his/her staff to support job performance and knowledge; remain cognizant of, and remove, any barriers or obstacles that impede his/her staff from achieving objectives.
5. Participate in study start-up activities including protocol authoring, database design, study manuals, essential documents etc. with the mindset of “start with the end in mind” to ensure the operational team is poised for successful data to enable the program strategy.
6. Oversee site selection, patient recruitment and retention.
7. Author documents necessary for study initiation and execution; ensure other documents and manuals are provided for study initiation and execution.
8 Interact effectively with Sr. Management within clinical operations and cross functional areas to provide updates and communicate issues.
9 Manage drug supply needs by communicating with the relevant IVRS vendor, study sites and the Amicus Technical Operations team.
10 Work closely with Translational Sciences to ensure timely and appropriate shipping of samples.
11 Communicate regularly with Data Management to ensure data are being cleaned and coded appropriately and in a timely fashion.
12 Interface with other team members, including Clinical Research Associates, to be aware of issues at sites that require attention.
13 Other responsibilities may be assigned as required.
• BS or BA required; MS in the biological sciences (e.g. Biochemistry, Pharmacology) preferred; PMP certification highly desired.
Professional Work Experience Requirements
• Minimum of 5-8 years of relevant experience in a pharmaceutical or biotechnology setting; At least 1 year of clinical monitoring experience or equivalent is desirable.
• Managing orphan drug disease trials is desired
• Thorough knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, SOPs
Experience and Skills
• Solid scientific background; able to understand biomarkers and clinical endpoints
• Excellent command of MS Powerpoint, Word, Excel and Project
• Good written and oral communication and presentation skills.
• Demonstrated alignment with Amicus Mission Focus Behaviors
• Passion for rare disease and patient focused
• Ability and willingness to travel approximately 20% of the time (international and domestic).
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.
Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.