Position Summary: 

 

The primary role of this position is to provide data management oversight of vendors and work collaboratively with data managers, clinicians, study managers, biostatisticians, and statistical programmers in the planning, conduct, and execution of all phases of clinical studies.  This role will work strategically with our cross-functional teams and external partners to ensure that all data deliverables generated by ACELYRIN are accurate, timely, consistent, and executed with the highest Good Clinical Practice (GCP), Good Clinical Data Management Practices (GCDMP) and quality standards, in accordance with established contractual agreements, budgets and study timelines.  This position will also develop and maintain a clinical data management infrastructure consistent with and supportive of current and future process developments.

 

Responsibilities:

The Associate Director, Data Management will be expected to:

·       Oversee vendors and manage clinical data management workflow for global development programs ensuring all necessary data quality control measures are in place; manage deliverables across multiple studies and be responsible for all vendor(s) oversight for outsourced DM activities

·       Attend multidisciplinary project teams providing specific expertise on timeline development and deliverables related to clinical data 

·       Assist with clinical data related vendor identification through development and distribution of RFI/RFP and bid defense discussions in collaboration with cross-functional partners 

·       Participate, in consultation with cross-functional partners, in the development of clinical data related key performance indicators (KPIs) and key quality indicators (KQIs) to build into contractual agreements 

·       Be a stakeholder in the company-wide standards for electronic case report forms, case report form completion guidelines, data transfer/handling agreements, etc.

·       Be in the forefront for efforts to drive adoption of external innovations related to clinical data to accelerate drug development, optimize risk-based quality management, and enhance analytic capabilities

·       Review of clinical data related documentation including clinical protocols, Data Management Plans (DMPs), electronic Case Report Forms (eCRFs), Data Transfer Plans (DTPs), Data Management reports, eCRF Completion Guidelines, etc., liaising with colleagues in other functions to ensure alignment with high quality 

·       Participate in the development of the clinical components of regulatory submissions and transfer of clinical data as needed, ensure data deliverables meet regulatory submission requirements 

·       Oversee performance of external vendors responsible for clinical data deliverables (e.g., UAT, query quality, clinical data transfers, database cleaning, database locking and archival, etc.); ensure quality completion of all clinical data related deliverables 

·       Ensure all clinical data is collected, handled, transferred, stored via secure and authorized methods, ensuring compliance with General Data Protection Regulation standards and local privacy requirement standards including identification of any systems or processes necessary to fulfil requirements  

·       Working closely with clinical programming to oversee the planning and development of Clinical Data Management Systems (CDMS).

·       Participate in portfolio-level clinical data related risk identification, management, and mitigation efforts and report progress to senior leadership 

·       May participate in due diligence team in evaluating potential in-licensing assets or other mergers / acquisition discussions  

·       Manages internal staffing and performance management, including hiring, training, coaching and performance reviews for data management staff.

·       Participate in Quality Assurance audits and/or regulatory authority inspections 

·       Responsible for overall clinical data performance of regulated clinical trials including inspection readiness; responsible to implement regular quality checks including results reporting to senior leadership; Verify status information on data management activities is available and is acted on as needed  

·       Contribute to the development and improvement of department-level and cross-functional Standard Operating Procedures (SOPs), processes, systems, and tools

·       Work closely with pharmacovigilance, medical and clinical team members, when applicable, on all data handling, data review and data issue documentation/finalization

·       Manage, train and mentor other DM personnel at ACELYRIN and at vendors

·       Travel as needed to execute assigned responsibilities and tasks

 

Qualifications and Skills Required:

 

·       7+ years of clinical DM pharma/CRO industry experience with progressive management experience in data management space (minimum of 5 years of direct data management experience)

·       University/college degree (life science, pharmacy or related subject preferred)

·       Leadership experience leading teams, projects, programs or directing the allocation of resources

·       Experience with management of direct reports in a corporate environment and vendor management from study start-up through completion

·       Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor 

·       Clinical data management project management preferred

·       Proficient in Microsoft Office

·       Experience with VEEVA Vault and/or Medidata RAVE electronic data capture tools

·       Professional, proactive demeanor

·       Excellent written and verbal communication skills

·       Excellent interpersonal and project management skills to meet project timelines

·       SCDM and/or Certified Clinical Data Manager (CCDM) preferred

·       Knowledgeable of effective DM practices

·       Thorough understanding of CDISC standards, including CDASH and SDTM

·       Familiarity with MedDRA/WHO-Drug coding

·       Experience with data visualization tools and development of reporting capabilities (i.e., SAS, J-Review, Spotfire, MS Power BI, etc.)

·       Understanding of the drug development process and risk-based trial management concepts

·       Good understanding of regulatory guidelines and issues (i.e., ICH GCP), and understanding of the connection to DM deliverables

·       Experience in regulatory filings (e.g., NDA, BLA, MAA) preferred

 

 

Essential behaviors and ways of working:

 

·       Action Oriented

·       Problem Solving

·       Organization

·       Functional/Technical Skills

·       Priority Setting

·       Drive for Results

·       Strategic Agility

·       Intelligence Horsepower

·       Dealing with Ambiguity

 

ACELYRIN, INC, does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, 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.  Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.