Study Site Engagement Lead

7 days ago

Sydney, Australia Takeda Pharmaceutical Full time

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 Sydney Head Office reporting to the Head of Regional 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 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 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 timely feasibility, start-up, and recruitment. The SSEL provides support across Takeda therapeutic areas.
- The SSEL engages and provides additional value by advising and educating study sites while building and maintaining sustainable relationships with investigators and study site personnel. The SSEL supports country and site identification, feasibility, site selection, and study recruitment strategies, and mitigates barriers at the direction of Clinical Programs.
- The SSEL contributes to an effective 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 feedback from attending site qualification, initiation and booster (performed together with the CRO CRA) visits.

**Your Opportunities**:

- 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 the 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 partners with sites / CRO.
- Implement recruitment support when targets are not met (e.g. booster visits, phone calls).
- Work with the study team throughout the lifecycle of the study.
- Provide written feedback to the Clinical Operations Manager (COM)/Clinical Operations Program Lead (COPL) after every site visit and escalates any site or CRA concerns.
- Facilitate regional/country MA engagement where needed, with the 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.
- Attend study meetings, as applicable, and provide relevant updates to SSE team members.
- Attend kick-off meetings and investigator meetings.

**Your Skills and Qualifications**:

- Scientific degree (MD, Ph.D., 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 the pharmaceutical industry in R&D, Clinical Operations, or Medical Affairs.
- Have adequate clinical research 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**:
Demonstrates flexibility in schedule and willingness to travel frequently in the assigned country (required travel may be as high as 50% during busy periods).

**Flexible benefits we think you’ll love**:

- Competitive and equitable remuneration for all.
- We value a flexible and hybrid working environment and encourage our employees to work in ways that meet their life/work commitments and support their unique wellbeing needs.
- Additional paid leave at the end of the year to take a step back and relax however you choose.
- Variety of innovative well-being initiatives and access to the award-winning Thrive platform.
- Equal parental leave. We offer an inclusive framework of 12 weeks of equal paid leave to support new parents.
- Social connection. We offer regular formal and informal events for the team to connect and unwind.
- Every employee has access to our Em

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