Clinical Trials Manager | BioNJ Talent Services

Clinical Trials Manager

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury
Company Profile: 

Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We have a robust development pipeline of treatments for a range of human genetic diseases.

Our lead product candidate, migalastat, is a personalized medicine in late-stage development to treat individuals with Fabry disease on the basis of their genetic diagnosis. SD-101, a product candidate in late-stage development, is a potential first-to-market therapy for the rare genetic connective tissue disorder Epidermolysis Bullosa (EB). We are leveraging our biologics and Chaperone-Advanced Replacement Therapy (CHART™) platform technologies to develop novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other Lysosomal Storage Disorders (LSDs). Our lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease ERT that will be administered in combination with a pharmacological chaperone.

Job Description:

Position Summary

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
Manages clinical studies, including vendor management and oversight including CROs, IRB, DSMB.
Organize and participate in investigational meetings and site training.
Coach and mentor all staff under him/her; set objectives, solicit 360° feedback from stakeholders and conduct performance reviews to foster growth of staff.
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.
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.
Oversee site selection, patient recruitment and retention.
Author documents necessary for study initiation and execution; ensure other documents and manuals are provided for study initiation and execution.
Interact effectively with Sr. Management within clinical operations and cross functional areas to provide updates and communicate issues.
Manage drug supply needs by communicating with the relevant IVRS vendor, study sites and the Amicus Technical Operations team.
Work closely with Translational Sciences to ensure timely and appropriate shipping of samples.
Communicate regularly with Data Management to ensure data are being cleaned and coded appropriately and in a timely fashion.
Interface with other team members, including Clinical Research Associates, to be aware of issues at sites that require attention.
Other responsibilities may be assigned as required.

Qualifications: 

Requirements
BS or BA required; MS in the biological sciences (e.g. Biochemistry, Pharmacology) preferred; PMP certification highly desired
Minimum of 5-8 years of experience managing clinical studies 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
Solid scientific background; able to understand biomarkers and clinical endpoints

Experience and Skills
Excellent command of MS PowerPoint, Word, Excel and Project
Self-motivated and able to function with little supervision
Highly detail-oriented
Able to multi-task
Excellent interpersonal skills
Superior communication skills, both verbal and written; able to synthesize complex data and ideas and summarize for senior management
Good team player
Able to resolve conflicts in a diplomatic manner
Demonstrated leadership skills
Ability to manage up and down
Good negotiation skills
Solid problem-solving and decision-making skills

Travel
0-5%

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Quality Assurance