Area Study Start Up Lead
hace 4 meses
**Company Description**
Purpose:
The Area SSU Lead is responsible and accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned pipeline and Global Medical Affairs clinical studies within area. The role reports into the Area SSU Head and serves as a single point of accountability across the area for the delivery and execution of the site start up and maintenance activities for the assigned studies within the area. Note:
Area SSU Leads will report into the Area SSU Head but have an operational reporting line to Global SSU Leads. In the US, Area SSU Leads will report in through Area SSU COMs, who report to the Area SSU Head.
Purpose:
The Area SSU Lead is responsible and accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned pipeline and Global Medical Affairs clinical studies within area. The role reports into the Area SSU Head and serves as a single point of accountability across the area for the delivery and execution of the site start up and maintenance activities for the assigned studies within the area. Note:
Area SSU Leads will report into the Area SSU Head but have an operational reporting line to Global SSU Leads. In the US, Area SSU Leads will report in through Area SSU COMs, who report to the Area SSU Head.
**Qualifications**
Qualifications:
- Bachelor degree in health care or scientific field highly preferred, or equivalent years of experience required.
- A minimum of 6 years of clinical
- Research experience and preferably 4+ years of study start up management experience for the designated region.
- Must have hands on experience interpreting regional clinical research regulations and processes. At least 2 years of experience in line management of people, coaching and mentoring
- of staff and teams preferred.
- Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients). Proven leadership skills in a cross-functional global team environment, experience in working with remote/virtual teams, and an ability to influence and align stakeholders in a cross-functional, multi-cultural environment.
- Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making.
- Excellent interpersonal skills with the ability to build trust and
- communicate persuasively and with clarity, flexibility, and adaptability to changing requirements.
- Demonstration of successful program execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment.
- Demonstration of participation in successful initiatives, special projects, and activities that support the business.
- Advanced working knowledge of ICH and GCP guidelines and operational understanding of the area regulatory environment.
**Additional Information**
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
-
Specialist, Country Study Start Up
hace 3 meses
Ciudad de México, CDMX AbbVie A tiempo completo**Company Description** **Job Description**: The Specialist, Country Study Start Up proactively drives and executes all start-up and maintenance-related activities and deliverables for assigned studies and sites in their assigned country or countries. For studies that only involve one country, the Specialist, Country Study Start Up is responsible and...
-
Study Start Up Associate I
hace 1 mes
Ciudad de México, CDMX ICON Plc A tiempo completoStudy Start Up Associate I - Contracts & budgets - Mexico - Homebased ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a...
-
Specialist, Country Study Start Up
hace 7 meses
Ciudad de México ABBVIE A tiempo completo**Purpose**:The Specialist, Country SSU proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries. - Note: Specialists will report into their local country COM but have an operational reporting line to Area and Global SSU Leads_ **Primary...
-
Sso Study Start-up Manager
hace 6 meses
Ciudad de México Novartis A tiempo completo390215BR **SSO Study Start-Up Manager**: Mexico **About the role** Location: Ciudad de Mexico On this role, you will be responsible for The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone...
-
Study Start Up Associate I
hace 3 semanas
Ciudad de México, CDMX ICON Plc A tiempo completoStudy Start Up Associate I - Hybrid - Mexico City ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Study Start Up...
-
Study Start Up Associate
hace 2 meses
Ciudad de México, CDMX Icon plc A tiempo completoStudy Start Up Associate (All levels: I, II and Sr) - Remote - Mexico ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a...
-
Study Start Up Associate Ii
hace 6 meses
México ICON A tiempo completoThe Study Start Up. Assocate II, collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP. Embrace and contribute to ICON’s culture of quality and process...
-
Study Start Up Associate Ii
hace 6 meses
México ICON plc A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...
-
Study Start Up Associate I
hace 4 meses
Ciudad de México, CDMX Icon plc A tiempo completoStudy Start Up Associate I (Regulatory Submissions) Mexico City - Hybrid Scheme ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently...
-
Study Start Up Associate II Specialist
hace 2 semanas
Ciudad de México, Ciudad de México Icon A tiempo completoAt Icon, we are seeking a highly skilled Study Start Up Associate II to join our team. This role is an exciting opportunity for individuals who are passionate about delivering high-quality results in a fast-paced environment.Job Summary:The Study Start Up Associate II will be responsible for collecting, preparing, reviewing, approving, processing, and...
-
Study Start Up Associate I
hace 1 semana
Ciudad de México ICON A tiempo completoAs a Site Activation Partner/ Study Start Up Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive...
-
Study Start Up Associate I
hace 1 mes
Ciudad de México, CDMX ICON Plc A tiempo completoStudy Start Up Associate I - Site Activation Associate I - Mexico - Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s our...
-
Study Start Up Associate I-biotech
hace 7 meses
Ciudad de México ICON A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
-
Senior Clinical Trials Manager
hace 1 semana
Ciudad de México, Ciudad de México Healthcare Businesswomen's Association A tiempo completoCompany OverviewThe Healthcare Businesswomen's Association is a leading organization in the healthcare industry, dedicated to empowering women to achieve their full potential.About the RoleWe are seeking an experienced Senior Clinical Trials Manager to join our team. This role will be responsible for contributing to the delivery of clinical trial...
-
Study Start Up Associate Ii
hace 6 meses
Ciudad de México ICON A tiempo completoAs a Study Start Up Associate II you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions. You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes. You will be engaged in a wide range of interesting...
-
Study Start Up Associate Ii
hace 2 meses
Ciudad de México, CDMX Icon plc A tiempo completoStudy Start Up Associate II (Site Activation Associate) - Mexico - Homebased ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s our...
-
Country Study Operations Manager I
hace 2 meses
Ciudad de México, CDMX Pfizer A tiempo completoWhy Patients Need You Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary...
-
Regulatory Start Up Director for Clinical Trials
hace 1 semana
Ciudad de México, Ciudad de México National Museum of Wildlife Art A tiempo completoOverviewWe are seeking a highly skilled Regulatory Submissions Manager to join our Study Start Up team in Mexico City. This is an exciting opportunity for individuals with experience in clinical trial management to grow their career and contribute to the success of Medpace.
-
Study Start Up Associate I
hace 2 meses
Ciudad de México, CDMX Icon plc A tiempo completoStudy Start Up Associate I & II (Site Activation Associate) - Mexico - Homebased ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s...
-
Clinical Study Team Assistant Ii
hace 4 semanas
Ciudad de México, CDMX Parexel A tiempo completoIn Parexel FSP we are currently looking for a Clinical Study Team Assistant II to join our team in Mexico. The position will be remote. The Clinical Study Team Assistant II (CSTA II) is an essential part of the Core Study Team and is responsible for driving and/or supporting key clinical trial tasks for assigned studies to ensure compliance with ICH-GCP,...