Director, Data Management

Company Overview:

Protara is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes.

Protara was named one of the Best Places to Work by BioSpace, a leading industry news and job source. This honor demonstrates the company’s desirability in the recruitment marketplace, looking at various merits with an emphasis on culture, career growth and development opportunities, leadership and innovation.  Attracting and retaining top talent is integral to building a successful company in biotech, and we are committed to ensuring Protara provides our employees with an exceptional experience throughout their careers, even as we continue to grow.

Job Overview: 

This position is both a strategic and hands-on leadership role responsible for overseeing the design, implementation, and oversight of clinical data systems and processes across Protara’s multiple clinical development programs.  The Director, Data Management contributes to the long-term success of the function through data-driven strategies, innovation in systems and processes, and strong cross-functional partnerships. Will be responsible for projects that have been contracted with CRO’s and internal projects.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Development and execution of data quality strategies, risk-based data review plans, and cross-study harmonization.
• Direct the design, testing, validation, and maintenance of clinical databases and electronic data capture (EDC) systems.
• Ensure consistent application of CDM standards, tools (e.g., CDISC, Medidata Rave), and procedures.
• Oversee issues resolution and data integrity across outsourced vendors and internal teams.
• Provide proactive input into clinical protocol design to ensure data collection strategies align with scientific and regulatory requirements.
• Review and contribute to clinical protocols and statistical analysis plans to ensure alignment with data collection objectives; cross-project consistency and standardization of case report forms.
• Partner with internal stakeholders to align timelines and data delivery requirements.
• Participate in cross-functional study teams; influence protocol design, study setup, and data strategy from study start to submission.
• Actively support submission readiness, including data integration and final deliverables for regulatory filings.
• Participate in protocol development, clinical study reports (CSR), and submission activities.
• Manage relationships with CROs and third-party vendors, ensuring alignment with contractual deliverables and performance expectations.
• Establish standards and oversight processes for EDC setup, CRF development, data validation, discrepancy management, and database lock.
• Drive consistency and scalability through implementation of standards (e.g., CDISC/CDASH/SDTM) and SOPs.
• Development and improvement of clinical data management processes and tools.
• Participates in the evaluation of organizational needs, defining resource strategies, and managing departmental budgets and headcount planning.

Qualifications:

• Bachelor’s degree in related scientific discipline; advanced degree preferred.
• 10+ years of progressive experience in clinical data management for Director level, 8+ years of progressive experience in clinical data management for Director level, with significant leadership responsibility at a biotech/pharma organization.
• Expert knowledge of clinical data management.
• Deep expertise in industry standards including CDISC/CDASH, SDTM, ICH-GCP, 21 CFR Part 11, and regulatory submission requirements.
• Proven success leading large-scale global studies, vendor oversight and working in both in-house and outsourced models.
• Expertise knowledge and hands on experience with EDC systems (e.g., Medidata Rave, Veeva), clinical systems integration, and risk-based monitoring frameworks required.
• Exceptional leadership, analytical, and excellent communication skills with the ability to influence senior stakeholders and executives.
  
  

Computer Skills:

•  Must be proficient in MS Office Suite and EDC systems.

Certificates, Licenses, Registrations: none required

Other Skills and Abilities:

• Strong interpersonal skills, including ability to communicate effectively with diverse audiences and build strong relationships.
• Excellent written and oral communication and presentation skills.
• Ability to prioritize and multi-task successfully in a fast-paced environment.
• Excellent organizational skills and attention to detail are essential
• It is essential that this individual demonstrates the ability to work with highly confidential information.
• Ability to manage both day-to-day operations as well as project work in a fast-paced environment.
• Strong analytical and problem-solving skills.
• Ability to work both independently and in a collaborative team setting.
• Demonstrated experience working with and presenting to senior level management.
• Ability to work through uncertainty.

Physical Demands: 

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• This position requires minimal travel: average travel for this position is 5-10% with some variation based upon the demands of the business imperatives. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• No specific work demands.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

*Salary Requirements are between $225,000 - $230,000 based on job-related knowledge, experience, education, and skills demonstrated.  We offer a competitive Compensation & Benefits package including incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits.

Why You’ll Love Working at Protara 

• Friendly, open, and fun team-oriented culture that values unique & diverse perspectives.
• Company-wide dedication to profoundly impacting patients’ lives.
• Amazing culture whereby core values and behaviors are shared cross-functionally.
• Flexible working hours/schedule.
• Generous Paid Holidays and Unlimited PTO.

Protara is committed to being a diverse and inclusive workplace. Protara is an Equal Opportunity Employer and is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, creed, religion, national or ethnic origin, citizenship status, age, sex or gender, gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information or any other characteristic protected by applicable federal, state or local laws.