We are seeking a highly motivated and qualified individual to join our Clinical Operations Department as a Director/Sr. Director, Clinical Data Management and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team.
The Director/Senior Director of Clinical Data Management, reporting to the VP, Clinical Operations, will provide oversight for data management activities across ADARX’s clinical studies. This role involves building and leading a DM department, defining strategy, and establishing an efficient DM operating model. This role will be accountable for creating and maintaining data processes and standards, ensuring the seamless integration and quality of data from electronic data capture (EDC) systems and other clinical trial data sources.
In addition, this person will be responsible for building the standards for data collection, edit specifications, Data Management Plans, data systems validation and UAT, listing generation, as well as review of clinical data for completeness, accuracy, and compliance
Essential Responsibilities:
- Oversee all Data Management activities for ADARX’s clinical trials, including oversight of vendors involved in clinical data management.
- Lead and mentors CDM team members and contractors.
- Review protocols and develop study plans to ensure that data collection and case report form (CRF) design meet study objectives (i.e., System Validation Plans, Data Management Plans, Data Transfer Plans, Data Review Plans, Data Monitoring Plans, and Data Coding Guidelines).
- Create or review standards and specifications for CRFs, database build and validation, edit checks, external system integration, or for other systems and processes related to data while enabling near-real time data access for ADARx clinical trials.
- Collaborate with clinical development, biostatistics and clinical operations to develop short-term and long-term strategies to improve data management quality and efficiency.
- Accountable for deliverables to meet company goals.
- Prepare for audits and regulatory inspections by ensuring data quality of clinical database through implementation of CDISC compliance and review for completeness, accuracy and consistency in accordance with study plans.
- Provide subject matter expertise to study team members during all phases of the project life cycle, electronic data capture, external data standardization, and prior, during, and after internal and external audits and inspections.
- Manage the development and periodic review of Data Management specific SOPs, WIs, and templates while assessing metrics and implementing suggested improvements.
- Generate metrics, reports, dashboards, and analytics to measure the performance of Clinical Data Management team across the portfolio.
- Represent clinical data management as a Subject Matter Expert (SME) and build relationships with key vendors.
- Effective interaction with senior level management across multiple functions.
- Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
- Maintain all appropriate corporate standards for facility 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:
- BS/BA degree or higher in science, mathematics, computer science or a health-related field.
- At least 10 years of clinical data management experience in a regulatory environment in the pharmaceutical or biotechnology industry.
- Experience successfully leading a CDM team or group.
- Extensive background collaborating with CROs, vendors, and internal study teams.
- In-depth knowledge and experience with clinical systems.
- Possesses a comprehensive understanding of regulatory guidelines and industry standards and their application to DM.
- In-depth knowledge and experience with clinical systems.
- Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
- Strong problem-solving skills and a proactive attitude towards exploring new approaches.
- Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role.
- Proficiency working with Microsoft Office Suite Products.
Preferred Qualifications:
- Medrio experience is highly desirable.
- A track-record of impacting drug discovery programs through driving projects to key decision points.
Required Key Attributes:
- Demonstrates an appropriate balance of business and technical capabilities.
- Capable of actively identifying project challenges and risks and proposing appropriate and strategic solutions to issues.
- Must be able to work independently as well in cross-functional team settings with supervision as needed.
- 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:
We are a late-stage clinical biotechnology company dedicated to transforming cutting-edge science into next-generation RNA medicines across a wide range of therapeutic areas. Our goal is to control the expression of specific disease drivers with highly selective RNA targeted therapies, delivering life-changing treatments for patients with urgent unmet medical needs.
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.
215000.00 To 225000.00 (USD) Annually
