Associate Director Project 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 :

Key Relationship to reach solutions :

Date Posted

28-Jan-2025

Closing Date

27-Feb-2025

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.

Locations : India - Bangalore