Director, Data Management New New York, NY, Remote
Proteon Therapeutics Inc., New York, NY, United States
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 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.
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. The role will manage projects that have been contracted with CROs and internal initiatives.
Essential Duties and Responsibilities
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 issue 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.
Participate in the evaluation of organizational needs, defining resource strategies, and managing departmental budgets and headcount planning.
Qualifications
Bachelor’s degree in a related scientific discipline; advanced degree preferred.
10+ years of progressive experience in clinical data management for director‑level responsibilities with significant leadership experience 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 experience working in both in‑house and outsourced models.
Expertise 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 communication skills with the ability to influence senior stakeholders and executives.
Computer Skills
Must be proficient in MS Office Suite and EDC systems.
Other Skills and Abilities
Strong interpersonal skills, including the 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.
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 Minimal travel: average travel for this position is 5‑10% with some variation based upon the demands of the business imperatives.
Salary and Benefits Salary Requirements are between $225,000 - $230,000 based on job‑related knowledge, experience, education, and skills demonstrated. We offer a competitive compensation and 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.
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.
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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. The role will manage projects that have been contracted with CROs and internal initiatives.
Essential Duties and Responsibilities
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 issue 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.
Participate in the evaluation of organizational needs, defining resource strategies, and managing departmental budgets and headcount planning.
Qualifications
Bachelor’s degree in a related scientific discipline; advanced degree preferred.
10+ years of progressive experience in clinical data management for director‑level responsibilities with significant leadership experience 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 experience working in both in‑house and outsourced models.
Expertise 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 communication skills with the ability to influence senior stakeholders and executives.
Computer Skills
Must be proficient in MS Office Suite and EDC systems.
Other Skills and Abilities
Strong interpersonal skills, including the 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.
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 Minimal travel: average travel for this position is 5‑10% with some variation based upon the demands of the business imperatives.
Salary and Benefits Salary Requirements are between $225,000 - $230,000 based on job‑related knowledge, experience, education, and skills demonstrated. We offer a competitive compensation and 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.
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.
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