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Job Description

Sr. Manager, Study Site Engagement

Location: Buenos Aires, Argentina

Reports to: Associate Director, Study Site Engagement

Travel: Up to 50% during busy periods.

About the role:

Behind every clinical trial there are investigators and site teams doing the real work. This role exists to make sure they feel supported.

As Sr. Manager, Study Site Engagement, you are the local face of Takeda. You are the link that keeps our study teams, our research sites and our CRO partners working as one, and the person our investigators in Argentina come to know and trust. You will support study teams with trial operations from feasibility all the way through the Clinical Study Report, across our therapeutic areas, and you may also step into the role of SSE Study Lead for assigned programs.

Your value is in the relationship. You bring guidance and knowledge to your sites, you build partnerships that last well beyond a single protocol, and you make sure that what a site needs is heard inside Takeda. It is work for someone who genuinely enjoys people, and it contributes directly to our mission to bring better health to people worldwide.

How you will contribute:

Early engagement, country and site feasibility

• You will support the SSE Lead and Study Lead in building the site list for feasibility and site selection, tracking progress and raising anything that needs attention
• You will work closely with Medical Affairs, the local Clinical Operations team and CRO colleagues on site identification, always aligned with the global study team
• You will attend Pre Study Visits when agreed with the Study Lead, and keep country and site selection activities on track.

Study start up, from site selection to initiation

• You will help track start up hurdles and their resolution so that Site Initiation Visits and site activations happen as planned
• You will attend and support SIVs, and follow up on open items afterwards until the site, the CRO or the Takeda study team closes them
• You will join Investigator Meetings in the region when invited, staying connected with sites and CRO.

Enrollment and study conduct

• You will support recruitment strategy and activities when targets are not being met, through PR&R materials, booster visits or direct contact with sites
• You will interact closely with the local CRO team throughout the life of the study
• You will stay regularly in touch with priority sites in your assigned trials and keep study specific trackers current.

Beyond individual studies

• As SSE Study Lead you may help shape the global Site Engagement Strategy for a trial and adapt it to what each country actually needs
• You may develop long term strategic relationships with selected sites and site networks to improve their experience with Takeda
• You will use conferences, congresses and other site facing events to reach investigators beyond your usual territory, including those who do not yet know Takeda.

Skills and qualifications:

• Bachelor's Degree or equivalent in clinical practice, health care, life sciences or drug development. A clinical or advanced degree such as BSN, MS, MA, MBA or PharmD is preferred
• 7+ years of experience in clinical research with a CRO or a pharmaceutical company, focused on clinical trials. Roles such as Study Coordinator or Study Nurse working closely with CRAs count here. Lead CRA or managerial experience is welcome but not mandatory, and we look at your cumulative experience as a whole
• Extensive site management or monitoring experience across highly complex disease areas, with demonstrated site oversight capability
• Prior clinical trial experience in multiple therapeutic areas is required, and experience across all study phases is preferred
• Solid knowledge of clinical development processes with strong emphasis on site management, plus comprehensive and current regulatory knowledge including ICH-GCP
• Proven ability to communicate effectively with site staff and KOLs, and to lead, troubleshoot and influence for quality and delivery
• Strong organizational skills and comfort juggling competing priorities
• Effective written and verbal communication in English and Spanish
• Curious, creative and unafraid to ask questions, willing to introduce new ideas and solve problems in new ways
• Proficient with MS Office, in particular Excel, Word and PowerPoint
• Flexibility in your schedule and willingness to travel frequently within the assigned region, which can reach 50% during busy periods

As an expert professional within the organization, you develop innovative solutions to complex problems aligned with organizational objectives. Your work involves addressing intricate issues, requiring in depth analysis and judgment. You also engage with key contacts outside your expertise area and contribute to the development of new concepts and standards. Operating with considerable autonomy, you serve as a consultant to management and an external spokesperson on major matters, often working independently and leading function teams or projects. Additionally, you play a role in training and mentoring junior colleagues.

What you can expect:

You will go through a structured onboarding with the training you need, covering local regulations, Takeda and CRO SOPs and therapeutic area content, and a dedicated colleague will walk alongside you until you feel fully at home in the role. It usually takes around two months, and it is never rushed.

Locations

ARG - Field Based

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time