Associate Director Business Operations, Data Management

Warsaw, PL; Bangalore, IN; Gothenburg, SE or Cambridge, UK

Competitive salary and benefits

Bring out the best in each other, and yourself, by working together as one

In our dynamic environment, be supported by the brightest minds working together side by side. Agile and collaborative, we work cross-functionally, as well as externally, to thrive at pace.

Be encouraged and supported to think creatively in our dynamic environment. Here we are free from fear of failure, free to ask the right questions and make bold decisions.

The Business Operations team within both Early and Late Phase DM is accountable for activities that ensure the smooth running of our business. These include, Quality, Process and Training and Portfolio management.

We have a number of opportunities as follows:

Portfolio and Capacity – you’re accountable for ensuring that studies are assigned to various models such that there are resources available to oversee the effective delivery. You’ll need to be aware of all aspects of the portfolio and milestones to avoid over or under hiring and when to engage our staff augmentation models.

You’ll have a good foundation in Data Management and excellent industry GCP knowledge as well as the ability to collaborate with other functions and vendors in a pro-active way to ensure that the portfolio and pipeline are adequately resourced. There will also be a requirement to coach and mentor supporting staff. Typical accountabilities include (but are not limited to):

• Understands the portfolio and ensures adequate assignment of resources

• Manages resource requests in the relevant tools. Represents DM at capacity planning meetings

• Holds regular resourcing meetings to ensure that resources are being shared across TA’s as needed to avoid over hiring

• Works with alliance management on the staff augmentation contracts ensuring a continuous supply of staff by job description needed

Quality and Compliance – you’re accountable for ensuring that staff are adhering to quality guidelines as laid out by the Health Authorities and addressing any variance from these through waivers, CAPA’s and Quality incidents. The Associate Director Quality and Compliance is also responsible for ensuring that the function is audit ready and overseeing the generation of storyboards for help with both internal and external inspections. You will have proven experience of working in a quality team with a good foundation in Data Management and excellent industry GCP knowledge to independently lead implementation of CAPA and QI activities as well as coach and mentor supporting staff. Typical accountabilities include (but are not limited to):

• Maintain awareness of changes in HA guidelines and ensure that these are followed across the DM organization

• Development of QC/QA processes and guidelines

• Entry and tracking of any quality issues into the relevant systems ​

• Work with vendors to ensure all CAPA’s and QI’s are captured and closed and once closed ​action is being taken as recommended through the organisations ​

• Generation of checklists & GxP trainings.

Process and Training – you’re accountable for developing and maintaining process documentation that includes SOP’s, guidances, process maps and work instructions to enable the DM functions to work in the most effective way whilst ensuring compliance to HA guidelines. This position is also accountable for maintaining and scheduling training using different platforms such as virtual classroom sessions, web based trainings and read and understand so that staff have the knowledge about the processes that they need in order to fulfil their role. You will require a good foundation in Data Management and excellent industry GCP knowledge as well as the ability to collaborate with other functions and vendors who may be impacted by a change in the DM process. There will also be a requirement to coach and mentor supporting staff. Typical accountabilities include (but are not limited to):

• Manages updates to both internal and vendor processes when gaps are identified and agrees the need for new documentation where none is currently available. Ensures documents are reviewed and approved in the relevant systems

• Oversees DM process changes both internal and external and collaborates across functions to ensure impacts are understood and mitigated

• Supports OS-ticketing system/adhoc questions from early and late DM teams ​

• Manages the Subject Matter Expert (SME) Community of practice​

• Conducts lessons learned with the teams and feeds back into process as needed​.

For all roles, the essential criteria are:

• Bachelor’s/Master’s degree or equivalent

• Proficient knowledge of clinical development process

• Thorough knowledge of industry standards and resource needs to manage trials of differing complexities

• Proven ability to influence relevant stakeholders and global teams

• Demonstrated ability to proactively manage concurrent activities within a project

• Ability to manage risk and help prioritize across a portfolio

• Ability to think on their feet and provide guidance

• Thorough knowledge of FDA regulations and GCP/ICH guidelines

For all roles, the Desirable criteria are:

• Experience in working with vendors

• Experience in putting together training materials

• Experience implementing business processes

• Experience in managing change

Why AstraZeneca

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. Always committed to lifelong learning, growth and development.

So, what’s next?

Complete your application by the 12th June 2022.

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

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.