![AstraZeneca](https://media.trabajo.org/img/noimg.jpg)
Associate Director, Evidence Project Management I
1 miesiąc temu
Description
of Services)• Co-ordinate/manage timely contributions of AZ 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 ( ICF, study plans and guidelines), delegate responsibilities among the team as appropriate
• Ensure all required External Service Providers ( 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 providing budget 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
• Oversee study/EAP level performance against agreed upon plans, milestones and key performance metrics, EAP exit strategy
• Identify and report quality issues that have occurred within the study, proactively communicate findings and corrective action plans (CAPA) to relevant stakeholders
• Oversee periodic TMF QC and responsible for review of relevant sections/documents in accordance with SOP/Wiki
Specifically in the EAP space if assigned to, in addition to above:
• Lead program planning, set up, implementation and delivery of EAP in collaboration with local/regional/global medical and market access teams
• Participate in operational governance activities related to agreed CRO strategic and operational governance principles
• Perform vendor oversight to ensure EAP delivery to time, cost and quality
• Collaborate with vendors to ensure the EAP operational aspects are effectively undertaken and that they have clear remits for delivery
• Manage resolution of program specific issues and escalations with internal and external stakeholders
Requirements:
Essential:
▪ Bachelor’s degree required preferably in medical or biological science or equivalent by experience
▪ 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
▪ Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools
▪ 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
▪ Ability to look for and champion more efficient and effective methods/processes of delivering evidence studies focusing on key performance metrics around reliability, efficiency, cost and quality
▪ Proven ability to interact widely and effectively within the company across regions, functions and cultures
▪ Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment
▪ Strong strategic and critical thinking abilities
▪ Strong organizational and problem-solving skills
▪ Ability to manage competing priorities
Desirable:
▪ Experience and knowledge within compliant management of Early Access Program
▪ Advanced degree in medical or biological sciences or field associated with clinical research
▪ Experience of incorporating digital health and patent centric strategies into clinical studies
Date Posted
31-maj-2024Closing Date
29-cze-2024-
Associate Director, Statistical Programming
4 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatAssociate Director, Statistical Programming, Late Stage Respiratory & Immunology Location : Warsaw (PL) Salary: Competitive, with excellent benefits. Hybrid model of work : 3 days in office, 2 days remote per week Reporting to: Director, Statistical Programming (Late Stage Respiratory & Immunology) Would you like to lead a Programming team,...
-
Associate Director, Statistical Programming
4 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatAssociate Director, Statistical Programming, Late Stage Respiratory & Immunology Location : Warsaw (PL) Salary: Competitive, with excellent benefits. Hybrid model of work : 3 days in office, 2 days remote per week Reporting to: Director, Statistical Programming (Late Stage Respiratory & Immunology) Would you like to lead a Programming team,...
-
Associate Director, Study Delivery Management
1 miesiąc temu
Warsaw, Polska 9605 GSK Services Sp z o.o. Pełny etatWe are building a Global Clinical Delivery Team within our hub based in Poland and looking for Associate Director Study Delivery Management who will lead a group of Study Delivery Specialists (SDSs) and Study Managers (SMs), who will perform tasks and activities in support of studies being delivered on time, at budget and within ICH-GCP quality framework....
-
Warsaw, Polska Baxter Pełny etatVantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...
-
Associate Director, Procurement supply continuity initiatives
3 miesięcy temu
Warsaw, Polska Baxter Pełny etatVantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...
-
Real World Evidence Manager
4 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatAt AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. Every day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide. Our purpose is results-oriented and so is our approach. Becoming a more agile and creative company means building a...
-
Real World Evidence Manager
4 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatAt AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. Every day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide. Our purpose is results-oriented and so is our approach. Becoming a more agile and creative company means building a...
-
Director of European Project Management
4 tygodni temu
Warsaw, Polska Testronic Sp. z o.o. Pełny etatabout-project : We are seeking a dynamic and experienced Director of European Project Management to lead our project management team across Europe. The ideal candidate will possess a strong background in managing large-scale projects, proficient in driving change throughout an organization, possess excellent leadership skills, and a strategic mindset to...
-
Director of European Project Management
1 miesiąc temu
Warsaw, Polska Testronic Pełny etatWe are seeking a dynamic and experienced Director of European Project Management to lead our project management team across Europe. The ideal candidate will possess a strong background in managing large-scale projects, proficient in driving change throughout an organization, possess excellent leadership skills, and a strategic mindset to drive the successful...
-
Director of European Project Management
4 tygodni temu
Warsaw, Polska Testronic Pełny etatWe are seeking a dynamic and experienced Director of European Project Management to lead our project management team across Europe. The ideal candidate will possess a strong background in managing large-scale projects, proficient in driving change throughout an organization, possess excellent leadership skills, and a strategic mindset to drive the successful...
-
Associate Director, Attack Surface Reduction
1 dzień temu
Warsaw, Polska IQVIA Pełny etatThe Associate Director: Attack Surface Reduction role presents a dynamic opportunity to ensure the secure operation of the IQVIA global information technology (IT) infrastructure and processes through developing and implementing new cybersecurity safeguards, amending and improving existing safeguards, as well as contributing to implementation of necessary...
-
Associate Director, Poland
3 miesięcy temu
Warsaw, Polska Turner & Townsend Pełny etatCompany Description At Turner & Townsend we’re making the difference; transforming performance for a green, inclusive and productive world. Through the commitment, capability and care our team brings, we build trust between clients, suppliers, governments and society. Delivering better outcomes that have a positive impact on the world around us. ...
-
Associate Director, Poland
4 tygodni temu
Warsaw, Polska Turner & Townsend Pełny etatCompany Description At Turner & Townsend we’re making the difference; transforming performance for a green, inclusive and productive world. Through the commitment, capability and care our team brings, we build trust between clients, suppliers, governments and society. Delivering better outcomes that have a positive impact on the world around us. ...
-
Warsaw, Polska AstraZeneca Pełny etatStatistical Programming Associate Director, Late Stage Respiratory & Immunology Location : Warsaw (PL) Salary: Competitive, with excellent benefits. Hybrid model of work : 3 days in office, 2 days remote per week Reporting to: Director, Statistical Programming (Late Stage Respiratory & Immunology) Would you like to lead clinical studies,...
-
Warsaw, Polska AstraZeneca Pełny etatStatistical Programming Associate Director, Late Stage Respiratory & Immunology Location : Warsaw (PL) Salary: Competitive, with excellent benefits. Hybrid model of work : 3 days in office, 2 days remote per week Reporting to: Director, Statistical Programming (Late Stage Respiratory & Immunology) Would you like to lead clinical studies,...
-
Pharmacovigilance Scientists
4 tygodni temu
Warsaw, Polska 1925 GlaxoSmithKline LLC Pełny etatPharmacovigilance Scientists - Associate Director/ Director/ Senior Director Positions in GSK Safety Evaluation and Risk Management (SERM) - Specialty Safety Business. Exciting opportunities to make a significant impact on patients’ lives Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK...
-
Pharmacovigilance Scientists
1 miesiąc temu
Warsaw, Polska 1925 GlaxoSmithKline LLC Pełny etatPharmacovigilance Scientists - Associate Director/ Director/ Senior Director Positions in GSK Safety Evaluation and Risk Management (SERM) - Specialty Safety Business. Exciting opportunities to make a significant impact on patients’ lives Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK...
-
Associate Director Standards Developer
1 miesiąc temu
Warsaw, Polska AstraZeneca Pełny etatThe Associate Director Standards Developer is primarily responsible for leading the technical development, management and maintenance of AZ end-to-end Clinical Analysis & Reporting Standards activities in their area of expertise ( clinical coding, clinical dictionaries, and data analysis & reporting standards (SDTM, ADaM, TLFs)) with quality and timeliness,...
-
Associate Director Standards Developer
4 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatThe Associate Director Standards Developer is primarily responsible for leading the technical development, management and maintenance of AZ end-to-end Clinical Analysis & Reporting Standards activities in their area of expertise ( clinical coding, clinical dictionaries, and data analysis & reporting standards (SDTM, ADaM, TLFs)) with quality and timeliness,...
-
RWE Associate Site Manager
1 miesiąc temu
Warsaw, Polska IQVIA Pełny etatAssociate Site Manager with French Real-World Evidence Hybrid: EMEA Join us on our exciting journey! IQVIA Real-World Evidence (RWE) teams work with clients to help them collect and use real-world data to generate evidence to meet the needs of regulators, payers, providers, and patients. Our approach is unique in the industry and is defining the...