Kimberley Saunders
Whitburn,Scotland
Summary
Accomplished professional with expertise in project team leadership and client relationship management, driving process improvement and ensuring audit compliance. Demonstrates proficiency in database oversight and cross-functional collaboration, enhancing stakeholder communication through diplomatic means. Committed to mentorship and training, fostering action planning and metric management to achieve performance reporting excellence. Aspires to leverage technical proficiency for continued career growth in strategic roles.
Overview
16
16
years of professional experience
2016
2016
years of post-secondary education
Work history
Manager, Project Services, Set-up
IQVIA and its Affiliated Companies
09.2023 - 01.2026
- Provide day-to-day direction of staff and manage Client Delivery Team to achieve client and company goals and/or initiatives; Support direct reports and drive continuous improvement in processes and procedures used by project team; Perform duties and responsibilities of Project Manager/Set Up Project Manager when needed, for short-term or long-term assignments. Dedicated sponsor account support from set up perspective, managing studies under the account and managing study metrics.
- Business Title: Q Squared Solutions Manager, Project Services, Set-up
Lab Project Set Up Manager
IQVIA and its Affiliated Companies
11.2019 - 09.2023
- Develop the database design requirements which include configuration (project specific kit contents, laboratory events, requisitions, medical reports), programming for full protocols and protocol amendments, and developing and maintaining client design standards as applicable in accordance with the requirements of the Clinical Protocol.
- Perform database configuration and programming review and approve verification unit testing
- Collaborate with colleagues during planning & handover meetings regarding project timelines, and project-related issues focusing on capabilities within Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management.
- Responsible for providing updates to the Project Manager regarding action/issues logs, status sheets and timelines during the start-up phase.
- Communicate and coordinate set-up activities with clients and internal customers to ensure that all milestones are achieved.
- Lead in the development of sponsor specific standards and program-specific set-up procedures.
- Lead in the identification and resolution of service level issues and where issues affect other projects within and across programs to ensure that any solution is employed universally.
- Ensure lessons learned are considered, shared and improvements included in study design process. Oversee the writing of protocol-specific laboratory instruction manuals / participate in the preparation and maintenance of the laboratory specifications document for each protocol within a program as appropriate.
- As required, prepare and present study-specific materials and services at Investigator, Kick-off and Bid Defense meetings.
- Participate in external and internal audits as required.
- Coordinate and mentor more junior staff; may assist in training new staff.
- Report on team performance against contract, customer expectations, and project baselines to management.
- Business Title: Q Squared Solutions Lab Project Set Up Manager
Snr Lab Project Services coordinator
IQVIA and its Affiliated Companies
12.2018 - 11.2019
- Liaising with Project Management in order to identify those tasks associated with the initiation of a project.
- Ensuring that Investigator information received from the study sponsor/CRO is accurately recorded in the QLIMS database and that, where information supplied has been incomplete, that this is notified to the sponsor.
- Liaising with the support services (e.g. courier companies) in order to expedite the transportation of patient samples.
- Liaising with the appropriate Q Squared Laboratories departments in order to facilitate project initiation procedures.
- Assisting Project Manager in the monitoring of patient specimen management receipt, lab analyses, test result approvals and reports, processing of outgoing shipments in order that all occur according to schedule.
- Ensuring that the Project Manager is made aware of any information that may influence the smooth running of a particular project.
- Acting as a secondary contact for the study sponsor/CRO.
- Assisting in the overseeing of project status. Attending project status meetings designed to inform relevant personnel of ongoing progress and commitments to deadlines.
- Participating, as required, in external and internal audits.
- Involvement in Local and Global Improvement projects as defined by the Director, Project Services Manager, Senior Project Manager or Project Manager.
- Business Title: Q Squared Solutions Snr Lab Proj Svcs Coord
Lab Project Svcs Coord
IQVIA and its Affiliated Companies
09.2016 - 12.2018
- Liaising with Project Management in order to identify those tasks associated with the initiation of a project.
- Ensuring that Investigator information received from the study sponsor/CRO is accurately recorded in the QLIMS database and that, where information supplied has been incomplete, that this is notified to the sponsor.
- Liaising with the support services (e.g. courier companies) in order to expedite the transportation of patient samples.
- Liaising with the appropriate Q Squared Laboratories departments in order to facilitate project initiation procedures.
- Assisting Project Manager in the monitoring of patient specimen management receipt, lab analyses, test result approvals and reports, processing of outgoing shipments in order that all occur according to schedule.
- Ensuring that the Project Manager is made aware of any information that may influence the smooth running of a particular project.
- Acting as a secondary contact for the study sponsor/CRO.
- Assisting in the overseeing of project status. Attending project status meetings designed to inform relevant personnel of ongoing progress and commitments to deadlines.
- Participating, as required, in external and internal audits.
- Involvement in Local and Global Improvement projects as defined by the Director, Project Services Manager, Senior Project Manager or Project Manager.
- Business Title: Q Squared Solutions Lab Proj Svcs Coord
Dance Coach
Signature Dance Squad
01.2010 - 09.2016
- Choreographing routines in various styles.
- Teaching young children and adults of various abilities.
- Dealing with customer orders.
- Cash handling and monthly fee checking.
- Attending appropriate training such as first aid, disability inclusion and keeping teacher's membership up to date.
- Attending meetings and contributing ideas to resolve any issues.
Bar staff
Bellshill Golf Club
01.2010 - 09.2016
- Serve customers.
- Cash handling, and balance till at end of each shift.
- House keeping.
- Supervise and train staff.
- Deal with complaints.
- Stock taking.
Education
MSc - Infection Biology
University of Glasgow
United KingdomBSC honours - Applied Bioscience
University of the west of Scotland
United KingdomSkills
- Project team leadership
- Client relationship management
- Process improvement
- Database oversight
- Cross-functional collaboration
- Audit compliance
- Mentorship and training
- Action planning
- Metric management
- Stakeholder communication
- Performance reporting
- Diplomatic communication
- Technical proficiency
Clinical Trial Experience
- IQVIA and its Affiliated Companies Clinical Trial Experience
- Study Phase: Phase 3
- Indication: Asthma
- # of Countries: 25
- # of Sites: 477
- Role: Project Coordinator
- Key Responsibilities: I am responsible for answering any questions or queries the client may have in an effective and timely manner. I complete reconciliations for any discrepancies between our database and the clients. I ensure that the study runs as smoothly as possible and resolve any issues to the best of my ability.
- Study Phase: Phase 2
- Indication: Cervical Cancer
- # of Countries: 6
- # of Sites: 40
- Key Responsibilities: I am responsible for answering any questions or queries the client may have in an effective and timely manner. I ensure that laboratory reports are released to site within the turn around time of testing if possible and investigate queries that may prevent a report from being released.
- Study Phase: Phase 1
- Indication: Solid Tumor Configuration
- # of Countries: 11
- # of Sites: 26
- Role: Project Manager
- Key Responsibilities: I am responsible for the European region for this study. I have the project manager role and therefore have little support and more freedom to make decisions. I ensure that queries are closed to ensure delays in testing and that there is clear communication with the client and CRAs to have any issues resolved.
- Indication: Lupus Erythematosus
- # of Sites: 46
- Key Responsibilities: I am responsible for the European and South African regions. I delegate and monitor tasks sent to the South African PC and CPC. I have learned the process of applying for MTAs for each site in South Africa and providing to the DOH for shipping permits. This requires continual monitoring and follow up with each participating lab and each doctor site. I manage any issues that arise in the study in a timely and effective manner.
- # of Countries: 0
- Role: Project Set-up Manager 1, Lab
- Key Responsibilities: Responsible for reviewing the client protocol and designing the set up documents accurately and accordingly. Responsible for reviewing the configured database for accuracy and quality. Responsible for communicating timelines and set up processes with the client in order to meet the requirements of the study and achieve the kit on site date for first patient arrival.
- # of Sites: 16
- Key Responsibilities: Responsible for reviewing the protocol and designing the kit and testing structure. I have frequent discussions with the client on how I can best design their study. This study is large with over 90 kits, including cycle X. Visits are split to help the ease of the site and the requirements of the study for possible future extension.
- Indication: Lupus Nephritis
- Special Population: Minors
- # of Countries: 18
- # of Sites: 139
- # of Patients: 415
- Key Responsibilities: Responsible for reviewing the protocol and designing the study documentation accurately per protocol requirements. Responsible for discussing documentation and study requirements with the client and keeping the client up to date with the progress of study set up and design.
Affiliations
- dancing
- walks and training with my dog
- boxing
Timeline
Manager, Project Services, Set-up
IQVIA and its Affiliated Companies
09.2023 - 01.2026
Lab Project Set Up Manager
IQVIA and its Affiliated Companies
11.2019 - 09.2023
Snr Lab Project Services coordinator
IQVIA and its Affiliated Companies
12.2018 - 11.2019
Lab Project Svcs Coord
IQVIA and its Affiliated Companies
09.2016 - 12.2018
Dance Coach
Signature Dance Squad
01.2010 - 09.2016
Bar staff
Bellshill Golf Club
01.2010 - 09.2016
BSC honours - Applied Bioscience
University of the west of Scotland
MSc - Infection Biology
University of Glasgow