Study Site Engagement Manager, Spain
hace 3 días
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a** Study Site Engagement Manager** in Spain (remote).
**Here, you will be a vital contributor to our inspiring, bold mission.**
**GOALS**:
- Study Site Engagement Lead (SSEL) is the regional face of Takeda for site relations and monitor engagement, supporting study teams with startup and recruitment and ensuring qualified CRO-CRAs are assigned to monitor clinical trial sites. The SSEL provides support across Takeda CDO therapeutic areas.
- The SSEL engages and provides additional value by advising and educating study sites, while building sustainable relationships with investigators and study site personnel. The SSEL supports country and site identification, feasibility, site selection, study recruitment strategies, and mitigates barriers at the direction of Clinical Programs.
- The SSEL contributes to a partnership between Takeda study teams, study sites and the CRO. The SSEL establishes communication with regional/country Medical Affairs (MA) and provides updates on study/site status.
- The SSEL supports Takeda study teams in their Sponsor Oversight responsibilities. through engaging with the Clinical Research Organization - Clinical Research Associate (CRO-CRA) on-site during routine monitoring visits.
- The purpose of this Monitoring Oversight Visit (MOV) is to ensure that CRO-CRA can perform clinical monitoring responsibilities according to the study protocol and ICH-GCP.
**ACCOUNTABILITIES**:
**Site Engagement**:
- Provide input to the study site list for feasibility and site selection.
- May be consulted for country selection and may provide input to country specific feasibility questions.
- Inform and partner with regional/country MA staff for site identification and feasibility support with study team.
- Attend qualification visits (PSVs) as requested or agreed upon.
- Provide regional/country MA with information on country and site selection.
- Attend and support site initiation visits (SIVs) and oversee CRA during SIVs where needed.
- Reduce identified start up and enrollment barriers.
- As invited, attends investigator meetings (in the region) and partner with sites / CRO.
- Implement recruitment support when targets are not met (e.g. booster visits, phone calls).
- Work with study team throughout the lifecycle of the study.
- Provide written feedback to the Associate Program Lead (APL)/Clinical Operations Program Lead (COPL) after every site visit and escalates any site or CRA concerns.
- Facilitate regional/country MA engagement where needed, with study team.
- Establish communication with regional/country Medical Affairs (MA) and provide updates on planned and ongoing global clinical studies, with a focus on upcoming feasibilities, study status and enrollment updates, specific site issues and HCPs contacted in the region/country.
- Distribute quarterly reports generated by GCDO to the Local Operating Companies (LOCs) in the assigned region.
- Attend study meetings, as applicable, and provide relevant updates to SSEL team members.
- Attend kick-off meetings, investigator meetings.
**Monitoring Oversight**:
- Review site monitoring visit reports and in-house essential documents.
- Perform a pre-MOV assessment during a pre-MOV interview with the CRO-CRA
- Assess whether the CRO-CRA performs monitoring activities according to the study protocol and ICH-GCP
- Escalate issues/queries to the COPL/APL and Clinical Quality Assurance(CQA).
- Create MOV report / summary and shares with CRO Partner and Takeda study team
- Recommend and agree next steps with COPL/APL and CQA following MOV findings.
- Work with service provider to schedule the co-monitoring visit. Provide relevant information and documentation to service provider to prepare for the co-monitoring visit.
- Schedule follow-up meeting with service provider and Takeda study team after the co-monitoring visit.
- Review co-monitoring visit report and share with Takeda study team.
- Hands over open action items to Takeda study team and CRO partner.
**EDUCATION AND EXPERIENCE**:
Education
- Scientific degree (MD, PhD, MA/MS, BA/BS) in pharmaceutical science, chemistry, biology, medical/healthcare or comparable background.
- 8 or more years of relevant job experience in related roles in pharmaceutical industry in R&D, Clinical Operations or Medical Affairs.
- Have adequate clinical trial monitoring experience with a knowledge of FDA or other local regulations and ICH GCP Guidelines.
- Have knowledge of Clinical trial processes.
- Knowledge of regional and country clinical trial regulations.
- Advanced knowledge of ICH-GCP.
- Healthcare industry knowledge.
- Common computer programs and databases.
**TRAVEL REQUIREMENTS**:
- Travel up to 50% during busy periods. Domestic and international travel is expected for this position following regional assignments and location of meetings, congresses and training.
**WHAT TAKED
-
Site Engagement Manager, Immunology
hace 7 días
Madrid, España Gilder Search Group A tiempo completo.TMAC (The Medical Affairs Company (TMAC)) - null, Spain The Site Engagement Manager (SEM) is responsible for providing operational expertise to sites through ownership/management of Site Engagement Strategy. The scope of this role includes the following:Duties and Responsibilities:Define and implement strategies for engaging clinical sites and...
-
Site Engagement Specialist
hace 3 semanas
Madrid, Madrid, España Icon Strategic Solutions A tiempo completo**About the Role**At Icon Strategic Solutions, we are seeking a highly skilled Site Engagement Specialist to join our team. As a Site Engagement Specialist, you will play a crucial role in supporting the conduct and patient recruitment of clinical trials at investigative sites.**Key Responsibilities**Participate in study-level feasibility activities by...
-
Sr. Clinical Site Manager
hace 2 meses
Madrid, España Engineeringuk A tiempo completo.As a Senior Clinical Site Manager, you will be joining the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.You will be responsible for the planning, initiation, coordination, and management of all monitoring and monitoring-related activities, as well as supervision of all site-related activities to...
-
Sr. Clinical Site Manager
hace 1 mes
Madrid, España Icon Strategic Solutions A tiempo completo.As a Senior Clinical Site Manager, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.You will be responsible for the planning, initiation, coordination and management of all monitoring and monitoring-related activities as well as supervision of all site-related activities to...
-
Site Patient Engagement Assistant
hace 6 meses
Madrid, España Allucent A tiempo completoAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Site Engagement / Patient Engagement Assistant to join our A-Team! The Patient Engagement Assistant will be responsible for...
-
Oncology Site Engagement Lead
hace 3 días
Madrid, España AstraZeneca A tiempo completoAt AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. This role is responsible for ensuring the local implementation of the operational site relationship management...
-
Sr. Clinical Site Manager
hace 2 meses
Madrid, España Engineeringuk A tiempo completoAs a Senior Clinical Site Manager , you will be joining the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.You will be responsible for the planning, initiation, coordination, and management of all monitoring and monitoring-related activities, as well as supervision of all site-related activities to...
-
Sr. Clinical Site Manager
hace 1 mes
Madrid, España Icon Strategic Solutions A tiempo completoAs a Senior Clinical Site Manager , you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.You will be responsible for the planning, initiation, coordination and management of all monitoring and monitoring-related activities as well as supervision of all site-related activities to...
-
Site Study Manager
hace 3 semanas
Madrid, Madrid, España Iqvia A tiempo completoAre you passionate about clinical research? IQVIA is seeking a highly motivated Clinical Research Coordinator / Study Nurse to join our team in Villamartin. This part-time role offers the opportunity to work on a clinical research study and contribute to maintaining a safe study environment.The ideal candidate will have excellent interpersonal skills, strong...
-
Site Manager
hace 7 meses
Madrid, España Johnson & Johnson A tiempo completo**Position Summary**: **Principal Responsibilities**: 1. Acts as primary local company contact for assigned sites for specific trials. 2. May participate in site feasibility and/or pre-trial site assessment visits 3. Attends/participates in investigator meetings as needed. 4. Responsible for executing activities within site initiation and start-up,...
-
Site Manager Multi-tumour
hace 6 meses
Madrid, España Johnson & Johnson A tiempo completoFor More Than 130 Years, Diversity, Equity & Inclusion (DEI) Have Been Part Of Our Cultural Fabric At Johnson & Johnson And Woven Into How We Do Business Every Day. Our Commitment To Respect The Dignity And Diversity Of All Is Embedded In Our Credo. _ - We Know That The Success Of Our Business Depends On Having The Best Talent In A Workforce That Reflects...
-
Senior Site Manager
hace 4 meses
Madrid, España Johnson & Johnson A tiempo completoGlobal Clinical Operations (GCO) Senior Site Manager (1/2) Position Summary: Principal Responsibilities: 1 Acts as primary local company contact for assigned sites for specific trials. 2 Actively May participate in site feasibility and/or Site Qualification Visit. 3 Attends/participates in investigator meetings as needed, may be expected to help prepare...
-
Study Start Up Manager
hace 5 días
Madrid, España Ergomed A tiempo completoCompany Description Ergomed is a rapidly growing global clinical research company. We perform clinical trials for rare and complex diseases. Ergomed Plc is a public company on the London stock exchange. The company boasted 40% growth in its revenues in its last report. This success is due to the hard work of our highly skilled employees and our subsequent...
-
Clinical Enrollment Manager
hace 3 meses
Madrid, España Innovative Trials A tiempo completoStart Date: Mid November FTE : 0.2 Location: Spain Job Purpose The Clinical Enrolment Manager (CEM) will perform site optimisation services in order to boost patient recruitment for clients' clinical trials.The site optimisation services include, but are not limited to: Site Optimisation Calls - the telephone-based coaching of study sites by motivating...
-
Senior Site Manager
hace 6 meses
Madrid, España Johnson & Johnson A tiempo completo**Senior Site Manager, Early Development & Clinical Pharmacology**: We are looking for a Senior Site Manager, Early Development & Clinical Pharmacology (ED&CP) to serve as the primary contact point between the Sponsor and the Investigational Site for the conduct of complex early development and/or clinical pharmacology studies. In other organisations, the...
-
Clinical Enrollment Manager
hace 2 meses
Madrid, España Innovative Trials A tiempo completoStart Date: Mid NovemberFTE: 0.2Location: SpainJob PurposeThe Clinical Enrolment Manager (CEM) will perform site optimisation services in order to boost patient recruitment for clients' clinical trials. The site optimisation services include, but are not limited to:Site Optimisation Calls - the telephone-based coaching of study sites by motivating them to...
-
Clinical Enrollment Manager
hace 3 semanas
Madrid, España Innovative Trials A tiempo completoStart Date: Mid NovemberFTE: 0.2Location: SpainJob PurposeThe Clinical Enrolment Manager (CEM) will perform site optimisation services in order to boost patient recruitment for clients’ clinical trials. The site optimisation services include, but are not limited to:Site Optimisation Calls - the telephone-based coaching of study sites by motivating them to...
-
Senior Site Manager
hace 9 meses
Madrid, España Johnson & Johnson A tiempo completo**Position Summary**: contribute to process improvement, training and mentoring of other Site Managers. **Principal Responsibilities**: - Acts as primary local company contact for assigned sites for specific trials. - May participate in site feasibility and/or pre-trial site assessment visits - Attends/participates in investigator meetings as needed. -...
-
Study Operations Manager I
hace 3 semanas
Madrid, España Parexel A tiempo completoAt **Parexel FSP**, people make a difference. We have a key mission: to prevent and treat disease by bringing important new medicines and therapies to patients in need. We achieve this important goal through the expertise, experience, innovation, and commitment of our employees around the world. Our employees have the opportunity to do meaningful things...
-
Site Care Partner Senior Manager
hace 4 meses
Madrid, España Pfizer A tiempo completoThe Site Care Partner is the main Pfizer point of contact for investigative sites throughout a study life cycle; accountable for site start-up activities through activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies; accountable for site-level...