AstraZeneca Pharmaceuticals LP Clinical Research Manager (CRM) in Ukraine
The Clinical Research Manager (CRM) is accountable for delivering the committed part of all clinical interventional studies under their supervision according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations.
CRM who manages country within a cluster plays “Country Head” role, combining line management and other responsiblitiesas required. CRM within a “Stand-alone” country is line manager for all assigned personnel plus other responsibilities as required. In addition to line management, CRM is expected to lead local study team(s) and perform monitoring as needed. As part of the flexible capacity model it is expected that the CRM manages multiple roles.
CRM may also act as Local Study Team Leader (LSTL) for local study teams comprised of AZ staff, and third party providers as required, with training and communication maintained.
As assigned, CRM is accountable that study sites are identified, site qualifications performed, set up (as appropriate), initiated, monitored, closed and documentation archived.
· Leadership of group work and building the team spirit, including developing team style and behaviour
· Ensuring adequate resources for the studies assigned
· Ensure that the workload of the team(s) or direct reports is adequate
· Development and performance management of the team(s) or direct reports
· Ensure that the everyone in the team or direct reports have development and training plans, according to IDP process
· Contribute to high quality feasibility work
· Contribute to efficient SMM organisation and its functioning at country level by working closely with responsible SMM Director.
· Contribute to the quality improvement of the study processes and other procedures.
· Plan and organise coaching of the team members and all direct reports
· Ensure that the individual performance planning and review process is completed for all direct reports
· Prepare salary and bonus proposals of all team members or direct reports based on their performance in close collaboration with responsbible SMM Director and HR partner.
· Ensure all systems are continuously updated.
· Assist SMM Director or Local Study Leader/teams in forecasting study timelines, resources, recruitment, study materials and drugs.
· Provide direction to LSL/teams on major study commitments including resolving any key issues identified.
· Review of monitoring reports/follow up letters of all direct reports as per study monitoring and/or local QC plans.
· Perform necessary accompanied site visits for direct reports, supporting ongoing coaching and development.
· Support SMM region in initiatives/activities as agreed with SMM Director(s).
If CRM in a country has role of additional respsonsibility such as LSTL, please refer to LSTL Job description.
Minimum Requirements and Preferred Background
· University degree in biological science or healthcare-related field, or equivalent.
· Minimum 5 years experience in Clinical Operations (CRA / Sr. CRA / LSTL) or other related fields.
· Proven team building and people/organizational development skills.
· Excellent knowledge of spoken and written English.
· Good ability to learn and to adapt to work with IT systems.
Competencies and Skills
· Very good knowledge of the Clinical Study Process, AZ Procedural Documents and international ICH/GCP guidelines.
· Excellent knowledge of the Monitoring Process.
· Good understanding of the Study Drug Handling Process and the Data Management Process.
· Good knowledge of relevant local regulations.
· Good medical knowledge in relevant AZ Therapeutic Areas.
· Good knowledge of the Drug Development Process.
· Ability to deliver quality according to the requested standards.
· Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
· Ability to work in an environment of remote collaborators.
· Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.
· Integrity and high ethical standards.
· Excellent resource management skills.
· Excellent decision-making skills.
· Good financial management skills.
· Good delegation skills.
· Good conflict management skills.
· Good interviewing skills – responsibility for attracting, developing and retaining personnel.
· Good in handling crisis situations.
· Excellent team building skills also in cross-functional teams.
· Excellent interpersonal skills.
· Good intercultural awareness.
· Excellent organisational skills.
· Excellent analytical skills.
· Excellent influencing skills.
· Excellent negotiation skills.
· Excellent communication skills, verbal and written.
· Excellent ability to prioritise and handle multiple tasks.
· Excellent ability to have attention to details.
· Excellent ability in working according to global standards.