Associate Director, Study Data Manager

Typical Accountabilities:

• Provides CDM leadership for one or more assigned projects or indications 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 program and/or project level. Management and oversight of vendor contracts, resourcing and budget management and oversight of vendor performance for assigned programs, and projects.

• Communicates and negotiates effectively with all other Program 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 programs, (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.

• 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.

• 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.

• Demonstrates willingness to take on and lead any project level activity consistent with current or experience in support of study delivery.

• Performs any CDM related ad-hoc requests from Line Manager or other senior managers.

Typical People Management Responsibility (direct / indirect reports):

• Approximate number of people managed in total (all levels) - None
• Matrix Manager – (projects/dotted line)

What is the global remit? (how many countries will the role operate in?):

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

Key Relationship to reach solutions:

• Internal (to AZ or team): Head of Early Data Management; Statistical and Clinical Programmers; Statistician; Clinical Colleagues; Clinical Quality Assurance and Compliance; Core Team/Extended Study Team Members; Patient Safety Team; Biometric Operations
• External (to AZ): Third party vendors that support Data Management including CROs; Vendors conducting Patient Safety