(S18) | Study Site Engagement Lead - Italy (Remote)

(S18) | Study Site Engagement Lead - Italy (Remote)

29 ott
|
Takeda Pharmaceutical
|
Cerete

29 ott

Takeda Pharmaceutical

Cerete

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 Lead** in Italy (remote).



At Takeda, we are transforming the pharmaceutical industry through our R&D-driven; market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver **_Better Health and a Brighter Future_** to people around the world.



Here,

you will be a vital contributor to our inspiring, bold mission.



**OBJECTIVES**:



- Study Site Engagement Lead (SSEL) is the regional face of Takeda for site relations and monitor engagement, supporting study teams with timely start-up and recruitment and ensuring qualified CRO-CRAs are assigned to monitor clinical trial sites.

- Engages and provides additional value by advising and educating study sites, while building and maintaining sustainable relationships with investigators and study site personnel. Supports country and site identification, feasibility, site selection, study recruitment strategies, and mitigates barriers at the direction of Clinical Programs.

- Contributes to an effective partnership between Takeda study teams, study sites and the CRO and establishes communication with regional/country Medical Affairs (MA) and provides updates on study/site status.

- Supports Takeda study teams in their Sponsor Oversight accountabilities 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 is well-trained and informed to perform clinical monitoring duties according to the study protocol and ICH-GCP.



**ACCOUNTABILITIES**_:



- **



**Site Engagement:

**Provides support to clinical studies to ensure study deliverables are met. Activities will vary based on the needs of the clinical program or study phase and in line with the level of service agreed upon.



Engages and provides additional value by advising and educating study sites, building sustainable investigator and site relationships, and maintaining site communication as needed throughout the study.



Study start-up phase - Country and site feasibility

- Provides 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.

- Informs and liaises with regional/country MA staff for site identification and feasibility support in alignment with study team.

- Attends qualification visits (PSVs) as requested or agreed upon.



Study start-up phase - Post site selection to site initiation

- Attends and supports site initiation visits (SIVs) and oversees CRA during SIVs where needed.

- Mitigates identified start up and enrollment barriers.

- As invited, attends investigator meetings (in the region) and liaise with sites / CRO.



Enrollment and study conduct phase.

- Implements recruitment support when targets are not met (e.g. booster visits, phone calls).

- Interacts closely with study team throughout the lifecycle of the study.



- Provides written feedback to the Associate Program Lead (APL)/Clinical Operations Program Lead (COPL) after every site visit and escalates as appropriate any site or CRA concerns.

- Facilitates regional/country MA engagement where needed, in alignment with study team.



**Participation in following activities may vary based on assignment by Line Manager**



**Cross-functional role**:



- Establishes communication with regional/country Medical Affairs (MA) and provides updates on planned and ongoing global clinical studies, with a focus on upcoming feasibility studies, study status and enrollment updates, specific site issues and HCPs contacted in the region/country.

- Distributes quarterly reports generated by GCDO to the Local Operating Companies (LOCs) in the assigned region, as appropriate.



**SSE **Program **Lead **for assigned programs**:





- Attends study meetings, as applicable, and provides relevant updates to SSEL team members.

- Attends kick-off meetings, investigator meetings (in region).



**Monitoring Oversight**:

The SSEL may support Takeda study teams in their Sponsor Oversight accountabilities through conducting Monitoring Oversight Visits (MOVs) with the CRO-CRA during routine monitoring visits. The aim is to engage with CRO-CRAs across Takeda’s critical clinical studies, ensuring that they are well trained and informed to perform clinical monitoring duties according to the study protocol and ICH-GCP.



MOV Preparation activities:



- The SSEL prepares for the MOV by

- Reviewing site monitoring visit reports and in-house critical doc

Puoi trovare l'offerta di lavoro originale su Kit Lavoro:
https://www.kitlavoro.it/lavoro/50734378/s18-study-site-engagement-lead-italy-remote-cerete/?utm_source=html

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