Global Clinical Control and Outsourcing Manager
hace 2 días
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
**Global Clinical Control and Outsourcing Manager**
Within the Global Procurement Area you will provide all outsourcing, vendor management and financial management support to the Global R&D Clinical Department. with study teams in Grifols North America and Spain. You will work with internal teams that include acting as the liaison with the Legal, Compliance, and Finance Department and additionally, interface with vendors on all contract and finance related topics.
**What your responsibilities will be**
Pre-Award:
- You will prepare pricing scenarios to Sr. Management at the Study Protocol concept stage.
- You will be the responsible for all vendors outsourcing needs from Requesting for Information, vetting the vendor’s capabilities, preparing Request for Proposal (RFP) to conducting Vendor Bid Defense meetings.
- You will review and analyzes all vendor bids to ensure cost competitiveness and that it meets the RFP criteria. Reviews budget for accuracy and completeness.
- You will be the responsible for the contract negotiation process that includes multi-million dollar bids with major Clinical Research Organizations (CROs), other clinical vendors, clinical investigators/sites and medical consultants.
- You will interface with vendor Business Development personnel to maintain and resolve any client & vendor issues
- You will be the responsible for the vendor evaluation process with study teams including drafting the Vendor Recommendation justifying the vendors selected and the associated costs, which is presented to Executive Management for consideration to proceed with the vendor award.
- You will negotiate contract terms that include payment schedule, milestones, bonus/penalty and other conditions.
- You will work with Legal Counsel to finalize and execute Contract.
Post-Award:
- You will manage multiple global studies with multi-million dollar annual budget. Activities include:
- Attending weekly project meetings.
- Contact for vendors for everything involving the budget including Investigator Budgets.
- Work with Study Team to resolve any vendor issues or contract/financial related issues.
- Prepares the annual forecast and budget based on Study’s timeline and requirements.
- Prepares and explains monthly variance analyses.
- Updates forecast as needed.
- Provides financial progress to department with emphasis on budget and spend rate as needed.
- Performs month end closing activities including reviewing the month-end estimates by the vendors to be submitted for Accrual.
- Reviews and approves vendor invoices.
- Develops the Investigator/Site Budgets per the Protocol for North American Sites being managed internally. Negotiate with Sites to come to agreement on the budget. Use Cost Base Budgeting negotiation if necessary to maintain equity across all sites.
- Works with the CRO on any Investigator/Site Budgets that’s out of range or include anything outside of the original budget approved (ie: additional travel, etc).
- Completes the Contract Summary Form to be approved by Global VP in order to get Contracts executed by Grifols.
**Who you are**
- You have a Masters or Bachelor's degree in business or related field. Accounting or Finance degree a plus.
- You have a minimum of 5 years of experience in contracts for clinical development programs. Project or technical leadership experience required. Supervisory or management experience preferred.
- You have a proficiency level in English and Spanish.
- You have excellent knowledge of clinical drug development processes.
- You demonstrate business/financial acumen and thorough understanding of CRO cost models and budget as well as services and costs associated with functional service providers (e.g. IVR, Central Labs, Biostatistics, and Medical Writing, Imaging, medical equipment purchases/rentals).
- You bring forecast and budget management experience.
- You bring excellent knowledge of the costs of clinical procedures and estimates of clinical programs.
- You hold proven experience in developing relationships with key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into processes as appropriate.
- You are a team player able to form strong cross-functional relationships, demonstrating an ability to influence/persuade others.
- You have experience working with all levels of management and consulting with key business stakeholder with an ability to influence for greater outcomes.
- Yo
-
Principal Clinical Trial Manager
hace 2 semanas
Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completo**Description** **Principal Clinical Trial Manager - Oncology or Ophtlamology experience required** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical...
-
Trainne Clinical Affairs Data Management
hace 1 semana
Sant Cugat del Vallès, España Grifols A tiempo completoWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
-
Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completo**Description** **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based in SPAIN** **Experience as CTM in the management of global/multiple-countries studies and different types of vendors is required.** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate...
-
Sponsor Dedicated Clinical Trial Manager Ii/ Sr Ctm
hace 18 horas
Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completo**Description** Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based in SPAIN **Experience as CTM in the management of global/multiple-countries studies and different types of vendors is required.** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique...
-
Director Project Management
hace 2 semanas
Barcelona, España TFS HealthScience A tiempo completo**Director, PM / Global Clinical Operations Manager**: **TEMPORARY position (1 year contract)**: **About this role** TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full...
-
Clinical Trial Manager Ii/ Study Manager
hace 17 horas
Pol, Lugo provincia, España Syneos Health Clinical A tiempo completo**Clinical Trial Manager II/ Study Manager (Poland) - Sponsor-dedicated** **-** **(** **22007901** **)** **Description** **Clinical Trial Manager II / Study Manager - combination office and home based** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader,...
-
Sr Clinical Trial Manager. Barcelona or Madrid
hace 7 días
Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completo**Description** **Senior Clinical Trial Manager** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the...
-
Senior Manager Global Medical Affairs Immunology/neurology
hace 2 semanas
Sant Cugat del Vallès, España Grifols SA A tiempo completoWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
-
Clinical Trial Manager
hace 18 horas
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **Clinical Trial Manager II** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...
-
Senior Manager, Medical Pharmacovigilance
hace 2 semanas
Sant Cugat del Vallès, España Instituto Grifols SA A tiempo completoWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...