Clinical Operations Lead Job in Delaware (DE), Clinical Research Career, Jobs in AstraZeneca Pharmaceuticals
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Clinical Operations Lead job in Wilmington

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AstraZeneca Pharmaceuticals jobs
Delaware (DE), Wilmington
Job Code:  R-034996
Employer:  AstraZeneca Pharmaceuticals
Category:  Clinical Research

Country:  United States
State:  Delaware (DE)
City:  Wilmington


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.


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

•         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

•         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

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

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

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

•         Excellent mentoring skills and ability to develop others

Leadership Capabilities

•         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

ref: (R-034996)
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