Study Site Engagement Lead

Job Description

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Job Description

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 Poland (remote)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 ManagerCross-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 documents.
• Performing a pre-MOV assessment during a pre-MOV interview with the CRO-CRA

Conduct MOV:

• Assesses whether the CRO-CRA performs monitoring activities according to the study protocol and ICH-GCP

Follow-up activities after MOV:

• Escalates issues/queries to the COPL/APL and Clinical Quality Assurance(CQA), as appropriate.
• Creates MOV report / summary and shares with CRO Partner and Takeda study team
• Recommends and agrees next steps with COPL/APL and CQA in line with MOV findings

Outsourced MOV Management

• Liaises with service provider to schedule the co-monitoring visit. Provides relevant information and documentation to service provider to prepare for the co-monitoring visit.
• Schedules follow-up meeting with service provider and Takeda study team after the co-monitoring visit. Reviews co-monitoring visit report and share with Takeda study team. Hands over open action items to Takeda study team and CRO partner.

EDUCATION, BEHAVIOURAL, COMPETENCIES AND SKILLS:

• Scientific degree (MD, PhD, MA/MS, BA/BS) in pharmaceutical science, chemistry, biology, medical/healthcare or comparable background.
• 8 to10 years of relevant experience in the pharmaceutical industry in R&D , Clinical Operations or Medical Affairs.
• Adequate clinical trial monitoring experience and knowledge of clinical trials processes, clinical trials regulations as per regional/country requirements with a strong knowledge of FDA or other local regulations and ICH GCP Guidelines.
• Outsourcing/CRO knowledge-base
• Ability to work independently and in teams. Ability to work cross-functionally within an international environment.
• Business Acumen
• Analytical skills, organization, planning and time management skills.
• Relationship Management & Influencing skills
• Fluent in spoken & written English
• Willing to travel up to 60%. Domestic and international travel is expected for this position as per regional assignments and location of meetings, congresses and training.

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, colour, ethnic or social origin, or disability. Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

Locations

POL - Poland Remote

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time