Associate Director Project Data Manager

Associate Director Project Data Manager

Location: Warsaw, hybrid work (at least 3 days from office per week)

Responsible for the oversight of the Clinical Data Management (CDM) delivery of high-quality data via external partners or internally run studies for one or more assigned projects or an indication. Alternatively, acts as an expert on Clinical Data Management (CDM) projects and technology outside of CDM program support. Maintains an up-to-date awareness of trends/changes in external CDM approaches and serves as a subject matter expert in process development and improvement. May act as a team leader or provide training or coaching to junior colleagues within CDM.

Typical Accountabilities (include but not limited to):
• Provides CDM leadership for assigned projects, indications and/or studies dependent on size and scale of the project. Takes global accountability and serves as the second line of contact at the project level.
• Demonstrates leadership and operational expertise in the strategic planning and delivery of CDM deliverables at project level. Management and oversight of vendor contracts, resourcing and budget management and oversight of vendor performance for assigned projects and studies.
• Communicates and negotiates effectively with all other project level team members. Primary point of contact for Clinical Data Management (CDM) at the Global Program Team (GPT) level.
• Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent CDM processes and documentation across assigned projects, (i.e. ensuring consistency across data quality plans.)
• Provide oversight and expertise of external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards; give guidance on AZ standards, processes, systems and expectations to external partners, internal partners and third-party vendors.
• Responsible for proactive risk management and issue resolution/escalation connected to Clinical Data Management improvement or technology.
• Proactively provides suggestions to improve AZ Standards, CDM processes and technologies. May also act as a Subject Matter Expert in any of these areas.
• Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards.
• Specialist in TA specific data capture and standards, conducts lessons learned and disseminate across the organization as appropriate
• Provides data management expertise in supporting strategic and operational aspects of Data Management on project level.
• May act as a team leader or mentor Clinical Data Management colleagues and any stakeholder with operational processes used in studies and projects.
• Represents Clinical Data Management at cross functional forums, meetings and provides timely feedback to partners.
• Understands health authority requirements and provide input into the Clinical Data Management related activities associated with regulatory inspections/audits and liaison with Clinical Quality Assurance. May also assist with AZ QIs.
• Demonstrates willingness to take on and lead any project level activity consistent with current or experience in support of study delivery. May also act as Study Data Manager for assigned studies.
• Performs any CDM related ad-hoc requests from Line Manager. Support Line Manager with portfolio oversight.

Education, Qualifications, Skills and Experience:

Essential:

• University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree.
• Ability to successfully manage simultaneous trials and meet deadlines.
• Significant Clinical Data Management experience, preferable both from CRO and Pharma industry in more than one therapeutic area.
• Excellent understanding of clinical trials methodology, GCP, GDMP and medical terminology.
• Comprehensive knowledge of clinical standards, e.g. SDTM or CDASH.
• High attention to detail and a strong analytical mind-set.
• Demonstrates a comprehensive knowledge of database structures and of capturing and storing clinical information as they apply to CRF design, database development, data handling and reporting.
• Excellent interpersonal skills and proven ability to operate effectively in a global environment.
• Good written and verbal communication skills, negotiation, collaboration, conflict management and interpersonal skills.
• Cultural awareness.
• Experience of CRO and vendor management.

Desirable:

• Experience as a lead of a large Phase III trial or multiple smaller trials;
• Knowledge of SQL, 4GL, VBA or R software
• Experience of managing teams.
• Experience with Regulatory Inspections
• Project Management training