AstraZeneca Pharmaceuticals LP Clinical Study Operations Lead in Wilmington, Delaware

Description:

Lead and coordinate activities that ensure quality, consistency, and integration of

study data and progress operational deliverables to time cost and quality

objectives from Study start-up through study close-out activities and Clinical

Study Report (CSR). Work with US local study team, with internal and external

partners, on local studies across different phases of drug development and

different therapy areas.

Position Location: This role can be Remote Home Office Based or

located at AstraZeneca's site in Wilmington Delaware.

Accountabilities/Responsibilities:

·

Coordinate operational aspects of AZ Sponsored studies

from Study start-up through CSR/Publication.

·

Lead and/or participate in activities that ensure

quality, consistency and integration of study data to agreed time, cost and

quality objectives

·

Interface with field monitoring CRAs, Local study team

leader (LSTL) and global study team (GST)

· Establish and maintain interactions with key stakeholders including the facilitation of

communications with GST, Strategic Partners, Academic clinics and

investigational study sites, as appropriate, and external service providers

(Third Party Vendors) to identify and resolve operational feasibility issues,

facilitate study start-up activities, and ensure Operations deliverables to

time, budget and quality objectives

· Implement globally agreed Operations and Clinical Development strategies including

processes and use of technical systems related to Operations

·

Contribute to the development of Operations

documents as appropriate as well as any updates/amendments to those

documents

· Ensure timely entry and/or update appropriate information into AstraZeneca tracking

and communication tools (e.g. IMPACT)

· Ensure the supply of study materials and Investigational product by liaising with Clinical

Supply Chain or external service providers as appropriate

· Contribute to the planning and conduct of any local internal and external meetings (e.g. Investigator/Monitors meeting)

· Monitor study conduct and progress, proactively identifying to and resolving with the

LSTL, issues which may impact delivery of the study or to the necessary

quality, timeline or budget objectives

· Contribute to steering committees, submission assembly teams, regulatory defence teams, and Advisory Boards as necessary

· Contribute to ad hoc team productivity and efficiency by providing direction and

facilitating good team dynamics

· Provide input into non-drug project work including training activities, and development of

procedures as needed

Minimum Requirements –Education and Experience

· Bachelor of Science degree in related discipline, preferably in medical, biological, or

health related sciences, or equivalent work experience in directly related

fields

· Experience working on clinical studies, across different phases of drug development

· Relevant industry or health care experience

· Proven organizational and analytical skills

·

Understanding of the clinical study and drug development process and GCP/ICH

guidelines in relation to study delivery operational activities

· Computer proficiency

· Excellent knowledge of spoken and written English

Skills and Capabilities

Demonstrates ability and willingness to work and lead cross-functionally, e.g.

with internal and external partners, on global studies, across different phases

of drug development or different therapy areas

· Good understanding of clinical data flow

· The ability to develop advanced computer skills to increase efficiency in day to

day tasks

· Excellent verbal and written communication and presentation skills

·

Demonstrates ability to work independently, as well as in a team environment

· Proven ability to prioritize and manage multiple tasks with conflicting deadlines

· Excellent interpersonal skills and proven ability to facilitate team building and team

work

·

Willingness to travel both domestically and internationally

·

Demonstrates sound knowledge of GCP, AZ Procedural documents, as they pertain

to Study delivery systems and processes

·

Proactively identifies risks and issues and possible solutions

·

Demonstrates high standards and uses tactful persuasion to obtain desired

outcomes while maintaining effective, positive, organizational relationships

· Develops knowledge of therapy area through experience and review of scientific

literature, and demonstrates ability to learn new therapy areas

·

Demonstrates ability to prepare and deliver study related training materials

·

Demonstrates ability to plan, coordinate, and facilitate internal and external

meetings

·

Demonstrates professionalism and mutual respect

· Displays excellent organization and time management skills, excellent attention to

detail, and ability to multi-task in a high volume environment with shifting

priorities

·

Demonstrated Project Management skills (e.g. leading delivery team)

· Excellent mentoring skills and ability to develop others

Leadership Capabilities at level 2

· Commitment to Customers and Integrity

· Strategic Leadership

· Acts Decisively

· Drives Accountability

· Works Collaboratively

Internal and External Contacts/Customers - Some examples of

contacts/customers are:

· Marketing Company (Site Management & Monitoring) personnel

· External service providers and strategic partners

· Global Study Team

· Other R&D Hubs

· Other Skill Centers as appropriate