Clinical Trial Manager, Clinical Operations

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

Position Overview

The Clinical Trial Manager (CTM) works closely with various internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets. This position is responsible for ensuring the achievement of own or others' project goals and objectives. This person may have line management responsibilities. This person is able and willing to perform all duties or functions of subordinates.

Core Duties and Responsibilities, including but not limited to:

·        Manages the operational aspects of clinical trials

·        Manages the study project plan, including timeline, budget, and resources

·        Participates in protocol, CRF and strategy development, Clinical Study Report preparation, IND submission, as appropriate

·        Prepares metrics and updates for management, as assigned

·        Proactively identifies potential study issues/risks and recommends/implements solutions

·        Participates in and facilitates (RO/vendor selection process for outsourced activities

·        Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)

·        Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met

·        Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)

·        Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations

·        Participates in the development, review, and implementation of departmental SOPs and processes

·        Recommends and implements innovative process ideas to impact clinical trials management

·        Organizes and manages internal team meetings, investigator meetings, and other trial- specific meetings

·        Serves as a liaison and resource for investigational sites

·        Reviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments

·        Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function

·        Performs some or all of the Duties and Responsibilities outlined for Senior Clinical Research Associate, as needed

Essential Skills and Traits:

·        Knowledgeable in Good Clinical Practices and ICH guidelines and the application to the conduct of clinical trials

·        Experience in the conduct of clinical studies involving complex design issues (e.g. multiple arms, crossover, double blind, and multi center), in all phases of pre-approval clinical trials

·        Experience working in small companies, or an appreciation of and desire to work in a small company environment

·        A team player who will work well with all other functional areas and can effectively interact with individuals at all levels of the organization

·        Ability to work under pressure and timeline constraints

·        Excellent written and verbal skills required

·        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 4+ years of clinical operations experience with thorough understating of cross functional processes including clinical supply, data management, biostatistics, and medical writing

·        A minimum of 1-year supervisory 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.

Job Type: Full-time, exempt