Clinical Development Associate Manager

Job Description

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 Specifications (SS) through study close-out activities and Clinical Study Report (CSR). Work with and lead cross-functionality, with internal and external partners, on global studies across different phases of drug development and different therapy areas.

Accountabilities/Responsibilities:

• Coordinate operational aspects of AZ and Investigator Sponsored studies from SS/Proposal 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 Data Management Center representatives/Data Management Department, to facilitate the delivery of study data
• Establish and maintain interactions with key stakeholders including the facilitation of communications with MCs, 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 protocol development and the development of other Operations documents as appropriate as well as any updates/amendments to those documents
• Provide input and review data management deliverables (e.g. eCRF specification, Data Validation Specification, Data Management Plan)
• Contribute to review of new/amended/unique project Clinical Information Standards (CIS) Standards Repository Components
• Lead the preparation of study documents as delegated by Clinical Development Manager ( e.g. Informed Consent Form, Clinical Study Agreement, Patient Participation Card etc)
• Ensure timely entry and/or update appropriate information into AstraZeneca tracking and communication tools (e.g. IMPACT, ISSIS and Clinical Partners Portal)
• Ensure the supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers as appropriate
• Support the study delivery team and Clinical Advice and Assurance (CA&A) in the development of and implementation of audits and regulatory inspections
• Contribute to the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meeting)
• Monitor study conduct and progress, proactively identifying to and resolving with the Clinical Development Manager, 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 neededMinimum 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 othersLeadership Capabilities at level 2
• Commitment to Customers and Integrity
• Strategic Leadership
• Acts Decisively
• Drives Accountability
• Works CollaborativelyInternal and External Contacts/Customers - Some examples of contacts/customers are:
  
• Clinical Operations personnel
• Marketing Company (Site Management & Monitoring) personnel
• External service providers and strategic partners
• Data Management Centre
• CPT and therapy area personnel
• Other R&D Hubs
• Other Skill Centers as appropriate