Senior Clinical Trial Manager / Associate Director, Clinical Operations

Arialys is a biopharmaceutical company focused on how the immune system impacts CNS health, disease and treatment.

Position Overview

The Senior Trial Manager / Associate Director, Clinical Operations will be responsible for the implementation of multiple clinical trials within a therapeutic area. This person is responsible for the execution of the clinical trial operational plans to meet the overall development strategy and ensuring that clinical trials are conducted in a timely fashion and compliant with Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and regulatory guidelines, company goals, and budgets. Will oversee work performed by Contract Research Organizations (CRO) and other vendors. This person is able and willing to perform all duties or functions of subordinates.

Core Duties and Responsibilities, including but not limited to:

• Responsible for the development and maintenance of clinical trial operational plans including timelines, budgets, and resource requirements within a therapeutic area Responsible for the development and content of risk mitigation plans to ensure clinical trials are on time and within budget Responsible for the implementation of clinical trial operational plans ensuring that clinical trials are conducted in a timely fashion and compliant with SOPs, GCP, and regulatory guidelines, company goals, and budgets Responsible for the preparation of Clinical Protocols, Investigator's Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs) Leads CRO/vendor selection process for outsourced activities, including development of scope of services agreements, budgets, and plans and timelines Manages CRO/vendor agreements, ensuring that change orders and budgets meet clinical operations specifications Responsible for review of invoices for accuracy compared operational plans, budgets, and work known to be performed by CRO/vendors Manages CRO/vendors to achieve goals and ensures that performance expectations are met Participates in patient finding activities and the development of patient recruitment plans and back-up plans including genetic testing programs Identifies, recruits, and approves clinical investigators in collaboration with Medical Monitor and Clinical Operations leadership

• Ensures that all supportive study-related documents are completed (e.g. Monitoring Plan, Study Reference Manual, Laboratory Manual, Pharmacy Manual, Source/CRFs including electronic documents Ensures that all monitoring activities and processes are complete, including training of internal and external resources, and are compliant with SOPs, GCP, and regulatory guidelines, company goals, and budgets Development/coordination of study training for study team, investigational sites, and vendors Oversite of required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC/approvals Recommends and implements innovative process ideas that impact clinical trials and/or clinical program management Contributes to wider organizational goals and/or activities as assigned

Essential Skills and Traits:

• Strong knowledge in Good Clinical Practices and ICH guidelines and the application to the conduct of clinical trials High proficiency in clinical studies involving complex design issues (e.g. multiple arms, crossover, double blind, and multi center), in all phases of pre-approval clinical trials Strong analytical and problem-solving skills Proven ability to provide scientific and clinical expertise to a clinical development program Must be a demonstrated self-starter and team player with strong interpersonal skills Must have the ability to build and maintain positive relationships with management, peers, and subordinates Excellent written and verbal skills required Must display strong analytical and problem-solving skills Attention to detail required

Qualifications:

• Combination of educational and work experience demonstrating competencies to perform the duties and responsibilities of the position. Bachelor’s degree in a scientific discipline is preferred Minimum of 6+ years of clinical operations experience with thorough understating of cross functional processes including clinical supply, data management, biostatistics, and medical writing At least 4 years of clinical operations line management experience

Note: This job description is intended to convey information essential to understanding the scope of the position and is not exhaustive. Duties and responsibilities may be subject to change based on organizational needs.

Compensation:

In addition to a competitive compensation package with stock options, the Company also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance.

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.