Associate Director, Evidence Project Management
UK
PRA Health Sciences
Req #: 112596
Type: United Kingdom
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Overview: As a Evidence Delivery Director you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities: The Medical Evidence Delivery Team within Oncology Business Unit (OBU) is responsible for strategic planning and operational delivery of interventional and observational studies, externally sponsored scientific research and early access programs (EAP) You will lead the operational planning, delivery, oversight and budget management of company sponsored evidence studies and/or early access programs (EAP) within the assigned therapeutic area (TA) Responabilities * Study-level interface with externally managed/outsourced partners for studies planning and delivery * Serve as main point of contact for communication and escalation of issues * Mentor, coach and support the study team members (i.e. Evidence Project Management Managers, Sr Specialists, Specialists) * Lead a cross-functional study team in accordance with EMPOWER to ensure study progress as planned and driving achievement of milestones * Be primary point of contact for the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards * Ensure the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study in accordance with relevant SOPs and guidelines (e.g. Sponsor Oversight Plan, Description of Services) * Co-ordinate/manage timely contributions of core/extended members * Interface with key stakeholders cross-functionally, and/or external partners, to identify, manage and resolve issues affecting study delivery * Review protocol drafts and input operational perspectives/content into document and authoring team discussions * Provide input into and/or quality review and hold accountability for the development of essential study level documents (e.g. ICF, study plans and guidelines), delegate responsibilities among the team as appropriate * Ensure all required External Service Providers (e.g. CROs) are engaged at the study level (including execution of relevant vendors contracts) and are performing to contracted goals, timelines and budget, as well as adequate oversight is documented * Responsible for study budget management through the study lifecycle and for providingbudget progress updates to Dir EPM /Sr Dir EPM including any financial risks and mitigation plans (as part of the ongoing study change control process) * Maintain/report accurate cost forecasts throughout study, manage study spend within available budget & agreed tolerances * Manage/oversee financial processes (PO's, invoicing, cost reconciliation etc.), may delegate as appropriate * Responsible for setup of the study cost tracker * Monitor study risks throughout delivery and oversee team in the development/implementation of mitigations and contingencies Qualifications: You Will Have: * Bachelor's degree required preferably in medical or biological science or equivalent by experience * Experience and knowledge within compliant management of Early Access Program * Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area * Advanced degree in medical or biological sciences or field associated with clinical research * Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools * Experience of incorporating digital health and patent centric strategies into clinical studies * Ability to effectively work with Clinical Research Organisations/External Providers * Ability to mentor, develop and educate staff * Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives
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