Clinical Research Site Manager - VistaGen Therapeutics

Position Summary:

We are seeking a highly motivated and versatile Clinical Research Site Manager / Clinical Rater to join our team. In this role, you will play a pivotal part in the successful execution of our clinical trials and oversight of investigative site activities. The ideal candidate will have a strong background in clinical research (preferably in Psychiatry), exceptional problem-solving skills, and the ability to build strong relationships with site staff and stakeholders.

KEY RESPONSIBILITIES

Clinical Trial Management:

• Oversee and monitor clinical trial activities at investigative sites, ensuring compliance with protocols, regulatory requirements (GCP and ICH), and company standards.
• Assist in Pre-Selection Visits (PSV) and Site Initiation Visits (SIV) and training of any new site staff added post Investigator Meeting and study start.
• Perform site troubleshooting and issue spotting, proactively identifying and resolving challenges to ensure the smooth progress of clinical trials.
• Collaborate with cross-functional teams internally to address site-related issues and implement effective solutions.

Site Engagement and Relationship Building:

• Build and maintain strong relationships with investigators, site staff, and key stakeholders to foster a collaborative and supportive environment.
• Act as a liaison between the company, CRO (Contract Research Organization) and investigative sites, ensuring clear communication and efficient resolution of site-related queries. Provide training and support to site staff, as needed, to enhance their understanding of protocols, procedures, clinical assessments, and compliance with requirements.

Clinical Data Review and Reporting:

• Review and verify clinical trial data, ensuring accuracy and completeness in accordance with protocols and regulatory standards.
• Perform clinical quality review of data and source documents to ensure internal consistency of data and concordance with expected clinical profiles across data sources.
• Data literacy, including analyzing, interpreting, and questioning data. Develop analytical reports to identify patterns and trends at the subject, site and study level.
• Conduct reviews of clinical charts (paper and electronic), source documents, and case report forms.
• Assist in development of monitoring tools for use by CRO and other team members.
• Prepare regular reports on site performance, patient recruitment, and other relevant metrics, providing updates to internal teams and stakeholders.

Regulatory Compliance and Documentation:

• Build and maintain strong relationships with key internal and external stakeholders, including investigators, Key Opinion Leaders (KOL), CROs, and regulatory agencies.
• Stay updated on relevant regulations, guidelines, and best practices related to clinical research and ensure site compliance with these standards.
• Assist in the preparation of regulatory submissions and documentation, collaborating with regulatory affairs teams as necessary.

Continuous Improvement and Process Optimization:

• Identify opportunities for process optimization and improvement in clinical trial conduct, site engagement, and monitoring activities.
• Contribute to the development and implementation of best practices and standard operating procedures to enhance the efficiency and quality of clinical research operations.

QUALIFICATIONS:

• Master's degree in related field, may be substituted with experience.
• Minimum of 5 years of experience in clinical research, with a strong preference for Psychiatry background, preferably in a biotech or pharmaceutical setting.
• Psychometric rater experience required.
• Strong understanding of GCP (Good Clinical Practice) guidelines, regulatory requirements, and industry standards. CCRC and GCP current certification a strong plus.
• Excellent communication and interpersonal skills, with the ability to build rapport and maintain positive relationships with diverse stakeholders.
• Detail-oriented, analytical, and proactive, with the ability to identify issues and implement effective solutions.
• Proficiency in using Excel, Word, SharePoint, clinical trial management systems and related software tools.
• Willingness to travel to investigative sites on a frequent basis (approximately 50%).

Travel Requirement:

This position requires regular regional in-state and out-of-state travel, primarily in the central region of the USA, approximately up to 50% of the time.  

Compensation and Benefits

What we offer:

• Industry competitive compensation
• Performance-base bonuses
• Stock options
• Employee Stock Purchase Plan
• 401K plan
• A collaborative and innovative work environment at the forefront of biotech advancements.

Give your best, live wholesomely:

• Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents
• FSA and HSA
• Basic Life Insurance 2x Earnings & AD&D
• Employee Assistance Program
• Healthcare advocates group to help navigate the healthcare system

Work-Life Balance:

• Unlimited paid time off
• Flexible work schedule
• Remote work option
• Paid Holidays
• Mental Health Days
• Winter shut-down
• Casual work environment

We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.

The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often.

Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

This position requires the ability to lift and/or move up to 25 pounds occasionally. Evening and weekend work as necessary.

DISCLAIMER

The anticipated salary range for candidates who will work remotely is $105,000 to  $145,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc.

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company’s 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents.

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as general description of benefits and other compensation and it is not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

All Employee’s have rights under Federal Employment Laws and link to the three posters: Family. and Medical Leave Act (FMLA) Poster Know Your Rights Poster; and Employee Polygraph Protection Act (EPPA) Poster.

About Us:

Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other CNS disorders. Vistagen is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns, than those currently available for the treatment of anxiety, depression, and multiple CNS disorders. Vistagen’s pipeline includes six clinical-stage product candidates, including fasedienol (PH94B),itruvone (PH10), PH80, PH15, and PH284, each an investigational agent belonging to a new class of drugs known as pherines, as well as AV-101, which is an oral prodrug of an antagonist of the N-methyl-D aspartate receptor (NMDAR). Pherines are neuroactive nasal sprays designed with an innovative proposed mechanism of action that activates chemosensory neurons in the nasal cavity and can beneficially impact key neural circuits in the brain without systemic absorption or direct activity on neurons in the brain. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety, depression, and several other CNS disorders.

At Vistagen, we emphasize that mental health is foundational to living vibrant and healthy lives. We believe that healthy minds create healthy communities, and our core goal at Vistagen is to radically improve mental health and well-being worldwide – One Mind at a Time. We are change-makers committed to improving lives by developing innovative, science-based mental health care medicines with the potential to make the impossible, possible - to empower and support patients and their caregivers to achieve faster-acting efficacy without the side effects and safety concerns associated with current treatment options for anxiety and depression.

Vistagen Therapeutics, Inc. is committed to equal employment opportunity, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.

NO PHONE CALLS, PLEASE. PRINCIPALS ONLY