Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Study Site Engagement Lead in our Austrian office or remotely reporting to the Study Site Engagement Team Lead.
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 accomplish their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
Here, you will be a necessary contributor to our inspiring, bold mission.
- 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.
- 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 Visit:
- 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.
Your Skills and Qualifications:
- 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 up to 60% in busy period. Domestic and international travel is expected for this position following regional assignments and location of meetings, congresses and training.
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. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer.
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. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.
Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 4,751.92 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.
AUT - Austria Remote