Job details
Job type full-time
Full job description
Senior clinical trial manager
Position summary
The srClinical trial manager is responsible for the day-to-day activities associated with managing early phase gene therapy clinical studies and overseeing the clinical trial manager(s) assigned to those clinical studiesWorking closely with the senior director, clinical operations and collaborating with colleagues in other functions, the srClinical trial manager supports the operational team to ensure excellent operational oversight of clinical studiesThe srClinical trial 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
Oversee the study team inclusive of the clinical trial manager (ctm) and the matrix team.
Manages early phase gene therapy 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 feedback from peers 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 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 srManagement within clinical operations and cross functional areas to provide updates and communicate issues.
Manage drug supply needs by vendors, 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.
Be the primary point of contact for quality assurance; own capas and lead quality improvementInterface with other team members, including clinical research associates, to be aware of issues at sites that require attention.
Compliance with law and business ethics requirements
Other responsibilities may be assigned as required.
Requirements
Educational requirements
Bs or ba required or equivalent; ms in the biological sciences or equivalent (e.gBiochemistry, pharmacology) preferred
Professional work experience requirements
Minimum of 8 years of experience managing clinical studies in a pharmaceutical, biotechnology or contract research organization (cro) setting and at least 1 year of clinical monitoring experience or equivalent is desirable.
Managing trials in orphan or rare drug diseases and/or gene therapy is desired
Experience and skills
Monitoring/cra experience is a plus
Thorough knowledge of applicable regulatory rules and guidelines, e.g., ich, gcp, sops
Solid scientific background; able to understand biomarkers and clinical endpoints
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
Other skills/attributes
Demonstrated alignment with amicus mission focus behaviors
Passion for rare disease and patient focused
Travel
10%
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for allOur 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 priorityEmployee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellenceOur “three pillars of dei” are interwoven into our amicus culture and expands one person, one word, and one act at a timeFor 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.
Job type: full-time
Work location: multiple locations
