Nov 5 2020
GlaxoSmithKline is one of the leading global healthcare companies, driven by innovation and scientific developments. Our mission is to improve the quality of life, enabling people to do more, feel better and live longer.
We conduct research aimed at improving the quality of life in three basic areas : Pharmaceuticals, Vaccines and Consumer Healthcare.
In our activities, we strive to be a responsible partner, building trust-based relations with healthcare system participants, focusing on dialogue and transparent cooperation.
We are currently building a Global Clinical Delivery Team with the hub based in Poland and looking to fill several roles.
Study Delivery Manager will lead a group of Study Delivery Specialists (SDSs), who will perform tasks and activities in support of studies being delivered on time, at budget and within ICH-GCP quality framework.
This role will be critical to ensure adequate and knowledgeable resources are in place for delivery of the Pharma (Rx) and Vaccines (Vx) clinical projects.
Study Delivery Specialists’ Manager role is located in Warsaw.
Manages and leads a team of Study Delivery Specialists (SDSs) across Rx & Vx Global Clinical Delivery Management. This team will support all resource needs, requested at study level, but in opposition with the Study Delivery Leads (SDLs), the Study Delivery Specialist Manager (SDSM) has no study responsibilities.
Ensures appropriate level of resources of qualified and trained SDSs to support Human Subject Research studies delivery within deadlines, budgets and quality, according to ICH / GCP, company control documents and regulatory requirements.
People Management :
Recruits, retains, leads and develops a team of SDSs, supporting study delivery.
Leads and directs staff by providing key objectives, aligned to company vision and strategy, setting clear objectives, expectations and feedback on performance and opportunities for development.
Decides upon appropriate allocation of SDSs to clinical projects / studies to reflect business and development needs in collaboration with SDLs and TA / RDC Heads.
Establishes SDSs performance measurement, track performance and identifies corrective actions.
Contributes to SDS capability building by supporting onboarding and community forums.
Guarantee adequate oversight of the quality of clinical studies. Responsible to set and implement management monitoring of SDS roles-related processes.
Ensures that a level of Quality Control (QC) is embedded in SDSs day to day activities.
Ensures Harmonization of practice at task / activity / process level for SDS, to ensure consistency, high quality and efficiency.
Drives the implementation of new practices and best practice sharing.
Resource Allocation and budget :
Defines and analyzes resources requirements, as per study projections and business needs in collaboration with Asset Leads (AL) and TA / RDC Heads, as well as Integrated Resource Management (IRM) output.
Ensures resource prioritization according to Business priorities works hand in hand with the SDLs and TA / RDC Heads.
Supports TA / RDC Heads with budget associated to SDSs.
Sets-up and makes the interface with any Functional Service provider for study delivery activities.
Responsible for quality practices, management monitoring, control documents development, improvement support and training related to SDS role.
What skills and expertise you will bring to the role :
Master’s Degree in Scientific Discipline (General Science or Life / Health related Science Degree).
5-8 years of significant experience in managing clinical operations with strong knowledge of ICH / GCP and Regulatory requirements driving clinical development (both pharma and CRO experience will be considered).
Min. 2 years of experience in People Management and management of resources from different sources in different locations (internal, external, functional service providers).
Strong knowledge and understanding of clinical operations and activities, associated to study delivery.
Strong knowledge of ICH-GCP and Regulations.
Strong knowledge of written & spoken English.
Knowledge of Industry and CRO world, experience working with functional service providers.
Strong customer orientation, ability to work beyond silos with a strong service provider mindset.
Ability to manage and lead teams across geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others.
Proven experience in effective people management in global and remote environment (more than 10 staff members).
Effective at problem solving and conflict resolution.
Ability to set and manage priorities, resources, performance targets and project initiatives in a global environment.
Experience in international settings, able to build alliances and influence across national and cultural boundaries.
Strong communication and presentation skills, including strong ability to network and negotiate at all levels in the organization.
Excellent listening and coaching skills.