Associate Director, Project Data Manager

Introduction to role

Are you ready to make a substantial impact on people's lives with life-changing medicines? As an Associate Director, Project Data Manager, you will oversee the Clinical Data Management (CDM) delivery of high-quality data through external partners or internally run studies for one or more assigned projects or indications. You will act as a guide on CDM projects and technology, staying up-to-date with trends and changes in external CDM approaches. You may also lead teams or provide training and coaching to junior colleagues within CDM.

Accountabilities

• 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.

Essential Skills/Experience

• University degree or college diploma 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 Skills/Experience

• 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

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Make a meaningful impact on people's lives with life-changing medicines. Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It's inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people's lives better—from patients and their families to all of us in society.

Ready to take on this exciting challenge? Apply now!

WHY JOIN US?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

Help to shape our journey towards becoming a tech-enabled enterprise. Encouraged to look to the future, think strategically and innovate, we influence progress today. We are constantly introducing new solutions and technology through on our quest to grow through innovation.  We love it here because put simply, we make a meaningful impact.

Technology at AstraZeneca is a home for purposeful disruptors. Apply now to learn more about this exciting opportunity with a world-renowned pharmaceutical brand!

SO, WHAT’S NEXT?

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 11 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

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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 authorisation and employment eligibility verification requirements.