Associate Director, Project Data Manager

Associate Director Project Data Manager

Location: Warsaw

Job Description / Capsule

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

• CDM leadership: 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.
• Strategic planning and oversight: 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.
• Project level communication: 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.
• Business understanding and consistency: 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.)
• Oversight of service providers and teams: 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.
• Risk management and issue resolution: Responsible for proactive risk management and issue resolution/escalation connected to Clinical Data Management improvement or technology.
• Standards, processes and technologies: Proactively provides suggestions to improve AZ Standards, CDM processes and technologies. May also act as a Subject Matter Expert in any of these areas.
• Industry standards: Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards.
• TA specific standards and lessons learned: Specialist in TA specific data capture and standards, conducts lessons learned and disseminate across the organization as appropriate
• Project level data management expertise: Provides data management expertise in supporting strategic and operational aspects of Data Management on project level.
• Team leadership and mentoring: May act as a team leader or mentor Clinical Data Management colleagues and any stakeholder with operational processes used in studies and projects.
• Cross functional representation: Represents Clinical Data Management at cross functional forums, meetings and provides timely feedback to partners.
• Regulatory inspections and audits: 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.
• Project level activity support: 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.
• Ad-hoc requests and portfolio oversight: Performs any CDM related ad-hoc requests from Line Manager. Support Line Manager with portfolio oversight.

Education, Qualifications, Skills and Experience

Essential

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

Desirable

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

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.