Clinical Trial Manager, Ophthalmology

Job Description:

We are seeking a highly motivated and qualified individual to join our Clinical Department as a Clinical Trial Manager, with a focus on Ophthalmology and work as part of a team to drive success. 

The Clinical Trial Manager (CTM) is responsible for the oversight of clinical trials, from planning and development to execution and reporting in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and applicable regulatory requirements, with a focus in Ophthalmology.

Essential Responsibilities:

• Overseeing the conduct of clinical trials to ensure compliance with protocols and overall clinical objectives.
• Developing and implementing plans and strategies for clinical trials, such as Project Management Plan, Enrollment Plan, Monitoring Plan, Protocol Deviation Plan, etc.
• Plan and participate in Monitor and Investigator Meetings.
• Support the management, tracking and oversight of clinical site budgets/payments in relation to conduct of a clinical trial.
• Develop or provide input to patient information/consent, eCRF forms and completion guidelines, site instructions for specimen collections, study drug order forms, etc.
• Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to Clinical Team Members as appropriate.
• Manage and oversee contracted CROs and vendors; identify potential risks and resolve issues with CROs; establish vendor management plans and review quality metrics.
• Support safety reporting.
• Prioritize and escalate issues on multiple clinical trials, as needed.
• Communicate directly with trial site staff and investigators to support the relationship between the sponsor and site. Depending on experience, may co-monitor or participate in Sponsor oversight visits.
• Maintain and report metrics for trial tracking and clinical site performance, including patient recruitment and retention.
• Review and/or approve of IP release packages.
• Review monitoring reports for compliance with study protocols and GCP.
• Review protocol deviations and data listings.
• Manage IRB/IEC and regulatory submissions, as needed.
• May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with Clinical Team Members.
• May perform clinical data review of patient profiles, data listings and summary tables, including query generation
• Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
• Participate in project core team meetings as appropriate.
• Maintain all corporate standards for workplace safety.
• Other duties as assigned.

Essential Physical Characteristics:

Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.

On-Site Protocol:

Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

Qualifications:

• Bachelor or master’s in biology, pharmaceutical, pharmacology or equivalent scientific discipline.
• Experience in managing Ophthalmology trials required.
• Minimum 3 years of combined experience in managing/monitoring Phase 1-3 clinical trials.
• Experience in performing clinical site monitoring visits, including remote visits.
• Experience working in a cross-functional matrix environment, CRO management and oversight, and managing and overseeing vendors.
• Ability to work across global time zones (including EU, APAC).
• Possibility to travel up to 10%-20% both domestic and international.
• Proficiency working with Microsoft Office Suite Products, EDC, IRT.

Preferred Qualifications:

• Retina experience is highly preferred.
• Global clinical trial experience highly preferred.
• 5 years combined experience in managing/monitoring Phase 1-3 clinical trials.

Required Key Attributes:

• Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
• Must be able to work independently with supervision as needed.
• Excellent written and verbal communication skills and strong presentation skills are essential for this role.
• Strong problem-solving skills and a proactive attitude towards exploring new approaches.
• Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
• Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment.

Compensation:

• This is a full-time position, Monday-Friday, occasional overtime.
• Pay is commensurate with experience.
• Equity-based compensation
• Performance-based bonuses
• 401(k) with Company Match
• Medical, Dental, Vision
• Flexible Spending Account
• Life Insurance
• Employee Assistance Program
• Employee Discounts 
• Gym Membership
• Paid Vacation
• Paid Holidays
• Paid Sick, Jury Duty, Bereavement

Work Authorization:

• United States (Required)
• Background Check
• As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check.

Company Overview:

ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system.

ADARx currently has multiple active programs in development with the lead candidate in the clinic.  We are well-financed by a syndicate of renowned VC firms.

ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Disclosure Statement:

• The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
• Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
• The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law.
• Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses.
• Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.