JO B DESCRIPTION

ROLE: Clinical Trial Manager (CTM)

RREPORTING TO: Director, Clinical Operations

DEPARTMENT: Clinical

SCHEDULE: On-site; 4 days per week out of San Diego office.

ABOUT ARIBIO: AriBio is a rapidly growing clinical stage biotech firm dedicated to developing treatments for neurodegenerative diseases, including Alzheimer's. Our commitment to innovative, polypharmacological approaches targets the complex pathophysiology of these diseases. We are in the midst of a global Phase 3 program for Alzheimer's disease and are advancing multiple earlier-stage compounds. We seek a motivated and experienced CRA II who shares our passion for making a meaningful impact on patient lives in a dynamic environment.

JOB SUMMARY: The CTM provides management and support of clinical trials according to all applicable regulations and guidance, ICH/GCP, and SOPs, where applicable. The CTM participates in cross-functional teams and partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
• Maintain and manage multiple tracking systems related to study details, training, and trial metrics
• Contribute to the development/review of study materials, case report forms (CRFs), informed consent documents for clinical studies
• Assist with site feasibility, start-up and activation including document collection, ICF review, site access to study platforms, facilitate site questions.
• May conduct and/or attend PSVs, SIVs, IMVs, and COVs.
• Review monitoring visit reports
• Assist with site communications for updates, clarification or distribution of key information
• Attend study team meetings, produce and distribute meeting agenda and minutes
• Support with TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents
• Assist clinical finance and study lead with the review, tracking and management of study specific budgets
• Perform remote query and data review as needed to assist CDM
• Other duties as assigned.

MINIMUM EXPERIENCE, EDUCATION, CERTIFICATIONS, LICENSES

• Bachelor’s Degree required; in life science or equivalent preferred
• 5 years of experience in clinical research required
• Experience as a CTM required
• Broad knowledge of ICH, GCP, IRB/IEC, and local regulatory authority for clinical research required

PREFERRED EXPERIENCE

• Experience in global Phase 3 trials preferred
• Experience in CNS indication including Alzheimer’s disease preferred

SKILLS/QUALIFICATIONS

• Strong team player with a demonstrated track record of success in a cross‐functional team and fast-moving environment.
• Excellent organizational, computing, and oral/written communication skills.
• Ability to influence and formulate effective solutions.
• Strong critical thinking and decision-making skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to read and comprehend policies, procedures, instructions, etc., to write reports, to use logic and data to solve problems, to assess needs, and varying degrees of independence, judgment, and discretion.
• Willingness to travel as needed.
• Proficient knowledge of Microsoft Office Suite, CTMS, EDC, QMS and other management systems.

SUPERVISORY RESPONSIBILITIES

• None

WORK LOCATION & TRAVEL REQUIREMENTS

• This position is on-site and located at our US office in San Diego, CA
• Domestic and international travel maybe required (approximately 15%)

PHYSICAL REQUIREMENTS & ENVIRONMENTAL CONDITIONS

• The duties of this role are generally conducted in an in-office environment. As is typical of an office-based role, employees must be able, with or without an accommodation, to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others (in-person interactions with other persons in indoor and outdoor settings); stand and/or move about the office or in various environments or from one worksite to another.
• Able to travel, including international travel, without personal assistance.
• The above physical requirements and work environment characteristics generally reflect those of this position but is not an exhaustive list. Reasonable accommodations may be made to enable individuals with qualified disabilities to perform the essential functions of the position, provided that such accommodation does not impose an undue hardship on AriBio.

PAY TRANSPARENCY

The expected salary for candidates for this role is $110,000.00 - $140,000.00. The final salary offered to the successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc.

EQUAL OPPORTUNITY EMPLOYER

As an equal opportunity employer, AriBio is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by applicable law. All employees, officers, and representatives of AriBio are expressly prohibited from engaging in unlawful discrimination, harassment, or retaliation.

Consistent with all applicable requirements, AriBio will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless doing so would create an undue hardship on the company.

AriBio also complies with all applicable federal, state and local laws governing work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and Immigration Reform and Control Act.

Nothing in this job description restricts AriBio’s right to assign or reassign duties and responsibilities to this role at any time in its discretion. While this job description generally reflects AriBio' current assessment of the essential functions for this role, it is not intended to be a complete list of the duties and responsibilities of this role, and it does not limit or restrict the duties and responsibilities that may be assigned from time to time. The duties, responsibilities and job description of this role are subject to change at any time without notice.

Unsolicited resumes from third party vendors will not be accepted.