Associate Director, Clinical Data Management

Job Description:

Essential Responsibilities:

• Lead and oversee all clinical data management activities from study start-up through database lock, ensuring adherence to protocols, ICH-GCP, regulatory guidelines, and company SOPs.
• Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs to align data management strategies with program goals.  
• Provide strategic input and review for key data management documents including Data Management Plans (DMPs), CRFs, edit checks, coding specifications, and database design.
• Manage and provide oversight of CROs and external vendors for outsourced data management activities; ensure quality deliverables, timelines, and budget adherence.
• Ensure robust data cleaning and discrepancy management processes, SAE reconciliation, coding (MedDRA, WHODrug), and risk-based quality checks.
• Lead database lock and data transfer processes in collaboration with Biostatistics and Clinical Operations.
• Develop and maintain data standards, tools, and templates to improve operational efficiency and compliance.
• Mentor and supervise internal CDM staff as the team expands; provide training and performance management support.
• Support regulatory submissions by ensuring high-quality data and contributing to submission documentation and responses.

Essential Physical Characteristics:

On-Site Protocol:

Qualifications:

• Bachelor’s or advanced degree in life sciences, health informatics, or related field.
• Minimum 10 years of experience in clinical data management in the pharmaceutical, biotech, or CRO environment.
• Prior experience leading data management activities for Phase 1–3 clinical trials and regulatory submissions (e.g., IND, NDA).
• Strong experience in vendor oversight and eClinical systems (e.g., EDC, ePRO, IVRS, CTMS, etc.).
• Familiarity with state-specific labor laws and regulations is essential.
• Familiarity with CDISC standards (SDTM), MedDRA, WHODrug, and clinical coding practices.

Required Key Attributes:

• Must be able to work independently with supervision as needed.
• Must be collaborative, self-starting, and flexible.
• Excellent written and verbal communication skills are essential for this role.

• Strong organizational skills with attention to detail and accuracy.

• Ability to maintain a high level of confidentiality and exercise discretion.
• Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges.
• Understand project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
• Given ADARx's location in San Diego, California, familiarity with state-specific labor laws and regulations is essential.

Compensation:

• This is a full-time position, Monday-Friday.
• 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 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. 160738.00 To 190075.00 (USD) Annually