Study Site Engagement Manager, Italy Montà

Study Site Engagement Manager, Italy
Montà
Piemonte, Montà

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 Italy (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