Associate Director Program Data Leader PDL
Associate Director Program Data Leader PDL
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Salary Not Disclosed
1 Vacancy
Job Description
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Introduction to role
Provide expertise for CDM programs ensuring timely delivery of quality data and fostering positive relationships with collaborators. Youll be tasked with the oversight of leading and successfully delivering complex studies or projects while also engaging with external partners. Your role involves overseeing Lead Data Managers completing various tasks to guarantee the accuracy completeness and compliance of data crucial for publications and regulatory submissions of studies within a program. Additionally your involvement in shaping technical landscapes business strategies and healthcare environments through contributions to various initiatives is integral. Your proactive approach to sharing insights and experiences with colleagues both within and outside the department is crucial. Collaboration with peers across the data management function and throughout the organization to ensure consistent data management solutions are implemented across a program. Timely completion of data management tasks and providing technical expertise while overseeing the project deliverables from Contract Research Organizations (CROs) Functional Service Providers (FSPs) and vendors are also part of your responsibilities. Critical thinking teamwork communication and innovation are essential for improving data collection and delivering medicines.
Accountabilities:
- Ultimately accountable for the timely CDM (rCDI) delivery of fitforpurpose quality data serving as the primary CDM point of contact at a program level for key partners.
- Plans project manages and oversees CDMrelated activities for a program including resource requirements risk identification risk mitigation prioritization and timely issue resolution for one or more complex programs.
- Partners with Directors rCDI to facilitate mentoring and coaching for CDM staff.
- Collaborates and influences effectively in a consultative manner with internal and external partners modeling and encouraging teamwork and collaboration including addressing blocking issues.
- Ensures alignment of the CDM program to the development teams goals and vice versa to positively impact the study quality and outcome.
- Provides input into the program strategy as a member of or collaborating with seniorlevel delivery teams as appropriate (e.g. Global Project Team (GPT).
- Develops communication strategies to keep collaborators customers and team members well informed and updated on strategy plans performance etc.
- Contributes technical therapeutic and business expertise within and external to CDM including but not limited to current and new technologies and data flow CDM industry landscape data standards therapeutic area expertise outsourcing expertise established methodologies and process improvements.
Essential Skills/Experience:
- Bachelors degree in a scientific field or equivalent experience.
- Experience in clinical data management of 810 years or with recent and relevant experience managing projects including deliverables overseeing inspections budgets and resources.
- Expert knowledge of the clinical data management and clinical development process including the regulatory submission process for the regulatory agencies (FDA EU etc. and knowledge of CDASH MedDRA/WHODD dictionary coding and versioning digital technology and data visualization technology.
- Highly effective written and verbal communication skills are necessary to interact with personnel at all levels within and outside the company.
- Strong organizational skills demonstrating the ability to work on multiple complex projects simultaneously while independently managing responsibilities with effective time management and impactful outcomes.
- Strong ability to solve complex abstract problems in crossfunctional business collaboration and independent projects while demonstrating proactive drive sound decisionmaking and attention to detail.
- High proficiency with technology associated with current and evolving data management practices including electronic data capture and data aggregating with exposure to data visualization and analytics automated data bots machine learning/artificial intelligencebased process enhancements etc.
- The duties of this role are generally conducted in an office environment. As is typical of an officebased role employees must be able with or without an accommodation to use a computer; engage in communications via phone video and electronic messaging; engage in problemsolving and nonlinear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.
Desirable Skills/Experience:
- A masters degree or equivalent experience in a field related to science.
- Certification as a Certified Clinical Data Manager (CCDM) from the Society of Clinical Data Management.
- Experience with clinical trial and/or RealWorld Data.
- Good understanding of molecule and disease area strategies healthcare environments as well as strong scientific and technical expertise.
- Extensive technical/industry experience.
At Alexion you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients lives.
Ready to lead and inspire Apply now and take the first step towards a fulfilling career at Alexion AstraZeneca Rare Disease.
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Date Posted
03Mar2025Closing Date
16Mar2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in EVerify.
Required Experience:
Director
Employment Type
Full-Time
