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Central Global Study Associate

3 weeks ago

Bengaluru Karnataka, India AstraZeneca Full time

Typical Accountabilities:

- Coordinate SD system activities and collection of SD metrics. Facilitate maintenance of study delivery system data and implementation of system enhancements. Develop reporting tools for SD Systems. Maintain an awareness of the external Process and Technology environment to identify opportunities for Study Delivery
- Delivers centrally managed services across drug projects (e.g. document management support, Clinical Trial Transparency)
- Ensures Business Continuity for SD Processes and Systems
- Facilitates dynamic sharing of Study Delivery knowledge and establishment of best practice; Ensure and develop effective communications and aid in consistent communication within Study Delivery
- Participates in change initiatives relating to Study Delivery
- Meets high SHE standards and legal obligations
- Demonstrates willingness to take on any level project activity consistent with current or past experience in support of study delivery
- Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration

Typical People Management Responsibility (direct / indirect reports):

- Approximate number of people managed in total (all levels) - 0

What is the global remit? (how many countries will the role operate in?):

- 2 or 3 countries at a minimum of 40% of time

Education, Qualifications, Skills and Experience:

- Essential: University degree in biological science, health related field, licensed registered nurse or equivalent experience; Significant experience in the pharmaceutical industry working in an environment of clinical study delivery/clinical development processes; Working knowledge of clinical and pharmaceutical drug development process and associated government regulations, ICH and GCP; Demonstrated aptitude for process and technology; Demonstrated ability to work collaboratively in a team environment as well as independently; proven ability to facilitate team building and team work; Excellent written and verbal communication skills in English; Excellent negotiation, collaboration, interpersonal, problem solving and conflict resolution skills; Demonstrated ability to set and manage priorities, resources, goals and project initiatives; Demonstrated leadership ability in a team environment as well as ability to function independently; Ability to travel both domestic and international; Customer Focused; Performance Driven
- Desirable: Clinical study delivery operational experience; Ability to lead and contribute to non-drug projects, with internal and external partners, that supports worldwide and local studies across different phases of drug development and different therapy areas; Proven Conceptual and Analytical thinking; concern for standards and willingness to learn from others; Understands concept of Business Continuity Planning.; Invites input from each person, shares ownership and visibility; creates a climate of collaboration; Demonstrates operational expertise in risk management and contingency planning; Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of AZ and SD systems/software in an e-enabled environment; Has in depth knowledge of GCP, AZ Procedural documents, as they pertain to Study delivery systems and processes; Positive change management skills, individually, team and business seeing change as an opportunity to improve performance and add value to the business; Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement

Key Relationship to reach solutions:

- Internal (to AZ or team): - Study Delivery personnel;
- Study delivery team personnel;
- Clinical Development personnel;
- Study Site personnel;
- Regional Monitoring personnel;
- Other Skill Centres as appropriate
- External (to AZ): - External service providers;
- Marketing Company personnel