Associate Director, Process & Documentation, Clinial Data Management

Role based in Barcelona onsite 3 days office/2 days home

The AD Process & Documentation for Data Management (DM) plays a key role in promoting and branding Data Management. Ensures the efficiency of business operations and creates and implements changes or improvements to process & documentation as needed. Plans and leads the strategy for process simplification and harmonization and ensures this is communicated across stakeholders and end users. The AD Process & Documentation for Data Management plays a key role in providing functional process expertise working closely with Subject Matter Experts within the functions and beyond where required. Responsible for promoting and communicating activities in DM to stakeholders across the business and externally. Serves as the expert in Clinical Data Management Process development to provide oversight and advice to the SMEs regarding the CDM Governing documentation development and maintenance. Monitor regulatory technical and pharma-industry trends to implement continuous process improvements. This position is responsible for one of the key components that supports Business Operations within Data Management and will collaborate with the other Associate Directors to strengthen the infrastructure of the function.

Typical Accountabilities

Accountable for the review and update of processes to ensure that DM deliverables can be met in a harmonized simplified manner while remaining compliant with HA guidelines and ensuring quality and GxP compliance

Develops strategies for effectively communicating process changes internally and externally

Able to bring a six sigma approach to process to ensure best practices are being upheld

Evaluate and improve business processes. Brainstorm and collaborate with teams for new ideas to enhance processes

In close collaboration with Business Process Management continue to monitor and assess processes to ensure they are producing the desired outcomes

Liaises with counterparts in Process and Enablement to ensure that company SOPs are updated as necessary

Develop and produce high-quality informative and interesting communications that brand DM

Ensure all messaging aligns with key business strategies

Develop content for social media newsletters town halls and any other distribution channels

Produces videos to detail who we are and what we do

Develop reports that showcase activities in Data Management

Develop questionnaires that allow us to get feedback from stakeholders and baseline our business

Collaborates closely with cross-functional colleagues (e.g. in SM&M Study Management Programming) to understand and ensure connectivity and dependencies of DM processes on other functional processes are thoroughly considered when providing FPE input or working with PES to update processes.

ECMS - Leads facilitates supports work in the tool

SOP steward and trainer with functional SME support

Manages and coordinates the assignment of resources for the review cycles of Biometrics Data Management and Clinical Operations owned governing documentation and determines the appropriate CDM SME involvement in the review of such documentation. Interacts with Learning Standards & Insights (LSI) Clinical Directors and CBDM Directors in this capacity.

Represents and serves as the SME for Data Management during activities associated with all aspects of the LSI governing documentation system (AZDoc & AZLearn).

Partners with colleagues in LSI to ensure appropriate training curriculum is in place for DM staff

Translates business objectives into individual assignments and/or tasks

Collaborate and communicate with Biometrics Data Management Clinical Operations and partner CRO organizations to ensure coordination compliance and proper use of DM Processes in data standards database builds programming and/or reports in clinical studies

Leads the creation of the workstreams for developing new CDM governing documentation and supporting documentation

Provides oversight and advice to the workstream regarding the activities of creating SOPs Guidelines Job Aids and supporting templates and forms

Provide expertise and consultancy to TA Leads on interpretation of CDM governing documentation to ensure overall CDM quality and consistency.

Education Qualifications Skills and Experience
Essential

Bachelor in scientific discipline or related field with a strong understanding of biomedical data and analytics. Advanced degree is a plus

Relevant experience in a pharmaceutical biotech CRO or Regulatory Agency

Experience as a project manager and subject matter expert of special initiatives supporting DM activities

Ability to work independently under pressure meeting tight deadlines demonstrating high level of initiative and flexibility

Excellent organizational and analytical skills

Strong technical and problem-solving skills with experience of computer systems for Data Management.

Excellent understanding of clinical trial methodology GCP ICH GCDMP and medical terminology

Experience with technologies and best practices across multiple platforms

Demonstrated experience to support complex projects and crossfunctional teams including delivering to project and portfolio metrics

Excellent communication interpersonal and negotiating skills in relating to colleagues and associates internal/external to the organization and leveraging of those competencies to ensure continuous progress

Strong track record of building successful relations with supervisors peers suppliers customers partners and stakeholders is essential

Strong strategic experience and business analytics ability to distil research needs and define business technical and operational requirements

Strong team player

Desirable

Ability to multitask and monitor several activities on a daily basis

Six Sigma green belt certified

Ability to coach and mentor

Ability to take initiative to develop new strategies and outside-the-box- ideas for social media

Excellent media relations skills

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.