Senior Associate Clinical Trial Manager (Contractor)

 

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.

Position Summary

Assist the project teams and work effectively in a team environment to manage day-to-day activities associated with clinical trial operations.

The Senior Associate Clinical Trial Manager is responsible for assisting the Clinical Trial Manager in study start-up, execution and close-out activities to ensure overall operational excellence

Roles and Responsibilities

1.           Support the project management team, cross-functional activities, vendor management, and budget planning and tracking

2.           Oversee CRO as delegated by Clinical Trial Manager

3.           Author and review study related support materials created by clinical operations

4.           Develop presentations for executive and leadership meetings; prepare metrics/dashboards; oversee content in Share Drives.

5.           Manage site feasibility and participate in site selection

6.           Participate in CRF design

7.           Participate in review and approval of regulatory packet prior to site initiation

8.           Work with CTM or AD on patient recruitment and retention

9.           Manage tracking of all site information (Initiations, Patient enrollment, Monitoring visits, Close out)

10          Manage drug supply at sites

11          Assist with patient tracking to document patient visits and overall study progress

12          Oversee filing of essential documents and maintenance of the eTMF

13          Support Clinical Trial Manager / Associate Director / Director with meetings, including preparation of agendas and minutes and tracking action items

14          Provide logistical support for meetings and conferences; partner with Finance to plan and manage the budget as appropriate; and facilitate the planning and budgeting process

15          Support Clinical Trial Manager / Associate Director for CAPA resolution, maintain CAPA tracker

16          Identify and escalate risks and issues to Clinical Trial Manager / Associate Director.

Requirements

Educational Requirements

•            BS or BA Required

Professional Work Experience Requirements

•            2+ years’ experience as CTA in a pharmaceutical or biotechnology setting; experience as a study coordinator may be considered

•            • Thorough knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, SOPs

•            • Honed analytical, problem-solving, and critical thinking skills, and strong attention to detail

•            • Highly detail-oriented

•            • Able to multi-task

•            • Superior communication skills, both verbal and written

Experience and Skills

•            Excellent command of MS PowerPoint, Word, Excel and Project

•            Veeva Vault CTMS/eTMF experience strongly preferred

•            Good negotiation skills

•            Solid problem-solving and decision making skills

•            Excellent interpersonal skills

•            Self-motivated and able to function with little supervision

•            Able to resolve conflicts in a diplomatic manner

Other skills/Attributes

•            Demonstrated alignment with Amicus Mission Focus Behaviors

•            Passion for rare disease and patient focused

•            Good team player

Travel

•            Up to 10%

 

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.

 

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