Associate Director, Clinical Data Management

Associate Director, Clinical Data Management

Reporting directly to the Vice President of Clinical Development, this individual plays a key role in the development of data management strategies including outsourcing, oversight, and risk-based data management strategies, standards, and processes. The Associate Director, Data Management will bring deep knowledge of industry best practices, regulatory requirements, and systems and processes that support efficient and compliant clinical data practices.

Responsibilities

Leads and manages all clinical data management (DM) activities including database build, cleaning, reconciliation, and locking activities across multiple clinical trials to ensure timely, accurate, and complete data collection and analyses.

Develops and implements data management strategies, processes, and standards in alignment with Good Clinical Practices (GCP) and applicable regulatory guidelines (e.g., FDA, EMA, ICH).

Oversees the review of key data management documents and operational activities (e.g., data management plans [DMPs], case report forms [CRFs], CRF completion instructions, data validation specifications, and edit checks) outsourced to CROs ensuring adherence to cost, timeline, and data quality requirements.

Participates in clinical vendor selection for external DM vendors including responsibility for review of DM sections of proposals, budgets, statements of work and change orders.

Pilots and implements available digital / AI solutions to improve study efficiency and quality of data collection.

Collaborates closely with Clinical Research Operations, Medical, Pharmacovigilance, and Biostatistics to ensure seamless data flow and data review leading to clean datasets for analysis.

Ensures storage of all DM documents in the trial master file to support inspection.

Mentors junior staff and contributes to departmental growth and development.

Qualifications

Bachelor's degree in life sciences, health informatics, or a related field (Master's or higher degree preferred).

Minimum of 8 years of clinical data management experience in the pharmaceutical, biotechnology, or CRO industry, including at least 3 years in a leadership or supervisory role.

In-depth knowledge of CDM processes, regulatory standards (FDA, EMA, ICH-GCP), and clinical data standards (e.g., CDISC, SDTM).

Hands-on experience with EDC systems (e.g., Medidata Rave, Veeva, Zelta), coding dictionaries (e.g., MedDRA, WHO Drug), and data visualization tools a plus.

Proven ability to manage multiple projects and vendors simultaneously.

Strong leadership, organizational, and communication skills.

Experience supporting regulatory submissions is highly desirable.

Competencies : Multi-Tasking, Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational Skills, Adaptability, Strong Written and Verbal Communications.

Working Conditions : Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a hybrid position based in Xeris' Chicago office. A minimum of three days per week on-site is required. On-site requirements may change at management's discretion.

The level of the position will be determined based on the selected candidate's qualifications and experience.

As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.

The anticipated base salary range for this position is $140,000-220,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process.

NOTE : This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.