Clinical Study Manager II

What you will be doing:

• For a project or a group of studies, ensure effective interface between Central Laboratory (CL) and  Project Team, especially the Study Delivery Lead (SDL), Global Clinical Delivery (GCD), Precision Medicines & Vaccines Clinical Laboratory & Assay Portfolio, Human Genetics, by providing support related to HBSM.
• Have input in study protocol development (mainly clinical laboratory part), CL set up including CL instructions for investigators sites.
• Be main point of contact for the clinical study team and CL.
• Responsible for overview of HBSM in the assigned projects including support investigator sites (mainly based on the cooperation with the Local Delivery Leads (LDLs)) and testing issues in CL.
• Be the HBS custodian for the study, from study start to study end according to the HBSM SOP and related written standards.
• For each study, define the operational set-up to align HBS flows, testing activities and data flows (in cooperation with Data Management) and assure it is in line with the other stakeholder’s constraints.
• Own the HBSM Plan and Samples Risk Assessment process and documents. Ensure that all study related activities are operationally set-up and conducted in line with the approach agreed with the clinical study team.
• Oversight of chain of custody of HBS throughout the lifecycle of the study, including site - central lab and provide consultations for HBSM CT in case of HBSM by Third Party Laboratories.
• Follow up on study KPIs, identify trends and ensure problems with HBSM are addressed.
• Act as Subject Matter Expert (SME) for one or several processes of the team. Ensure standard processes and ways of working are in place across all project and studies for all key activities of LSMs, e.g., HBS custodian, study set-up with central laboratory, HBSM Plan process, blinding & reconciliation strategy, etc.
• First point of CL escalation for the clinical study teams. Understand, mediate and solve complex issues related to LSM deliverables and escalate as required.
• Monitor study related activities to provide management with consolidated information on central laboratory, sample management, data delivery, CL budget review & annual forecast as well as key performance indicators to surface HBSM issues.
• Ensure alignment in the ways of working for a project or a group of studies.
• Support external and internal project audits in CL/HBSM part.
• Support CL database reconciliation with all CL related issues based on the strong cooperation with assigned Data Manager.
• Manage samples long term storage with input from HBSM CT teams.
• Adhere to the LSM RACI as an integral part of the LSM key responsibilities.
• Able to evolve in a changing and challenging environment, coaches the study team members to focus on value, building business agility and embracing change.
• Excellent networking capabilities and ability to influence and manage stakeholders at all levels of the organization. The ability to facilitate and lead cross functional meetings/challenge status quo and inefficient ways of working and need to be comfortable in a mediation role.

Educational Requirements (minimum expected):

• Master’s degree in medical/life sciences or equivalent background.
• Demonstrated expertise in Project Management beyond their own field of expertise.
• Demonstrated capability to integrate complex inter-departmental links, processes, databases, and systems.
• Demonstrated knowledge and competency in laboratory processes and extended knowledge of ICH-GCP/GCLP rules.
• Demonstrated fluency in spoken and written English beyond scientific English.

Job Related Experience (minimum requirements):

• At least 5 years of operational experience in clinical laboratory activities and clinical study conduct
• Proven experience in clinical project planning, project management and issues resolution
• Ability to quickly integrate with clinical development processes and global network to build strong partnership with lab vendors and
• stakeholders.
• Experience of managing business remote matrix network of internal and external stakeholders of multicultural and multidisciplinary people with different expertise and various scientific background
• Ability to align all the parties involved to build alliances and influence across national and cultural boundaries (up to 20 in different countries, including Africa and China)
• Experience in leading various operational meetings
• FDA or other competent authority inspection exposure
• Experience of budget management

You are:

• At least 5 years of operational experience in clinical laboratory activities and clinical study conduct
• Proven experience in clinical project planning, project management and issues resolution
• Ability to quickly integrate with clinical development processes and global network to build strong partnership with lab vendors and  stakeholders.
• Experience of managing business remote matrix network of internal and external stakeholders of multicultural and multidisciplinary people with different expertise and various scientific background
• Ability to align all the parties involved to build alliances and influence across national and cultural boundaries (up to 20 in different countries, including Africa and China)
• Experience in leading various operational meetings
• FDA or other competent authority inspection exposure
• Experience of budget management