Senior Manager, Study Site Engagement
Takeda · Sydney
Job Description
Objective / Purpose
- Local face of Takeda by contributing to an effective partnership between Takeda study teams, study sites and the Clinical Research Organization (CRO) (i.e., the Clinical Research Associate (CRA)/Monitor). Establishes communication with regional/country Associate Director, Study Site Engagement, and Medical Affairs (MA), provides updates on study/site status, and establishes site engagement study specific strategies.
- Supports study teams with trial operations from Feasibility through Clinical Study Report (CSR) within the assigned region or countries across Takeda therapeutic areas.
- Enhances engagement and offers added value by providing guidance and sharing knowledge with study sites, while establishing and nurturing long-term relationships with investigators and study site personnel. Supports country and site identification, feasibility, site selection, study start-up, study recruitment strategies, and mitigates barriers at the direction of Clinical Programs.
- Supports Takeda study teams as part of their day-to-day responsibilities and may act as an SSE-Study Lead (SSE-SL).
Accountabilities
Study Specific Engagement Activities
Early engagement - Country and Site Feasibility
- Supports the Study Site Engagement Lead (SSEL)/ SSE Program Lead (SSE-PL)/SSE Study Lead (SSE-SL) with the development of study site list for feasibility - site selection and aids in tracking feasibility progress and escalations for SSEL/LOC support.
- Reports any discrepancy on feasibility progress to SSE-PL/SSE-SL
- Liaises with SSE-PL/SSE-SL, MA, local Clinical Operations team (if available) and CRO staff for site identification and feasibility support in alignment with global study team.
- Attends Pre-Study Visit (PSV) as requested or agreed upon with the SSE-SL.
- Helps to follow up with country MA, local Clinical Operations team and keep track country and site selection activities.
Study Startup Phase - Post Site Selection to Site Initiation
- Supports the SSE-PL/SSE-SL in tracking start-up hurdles escalated to the team and their resolution to ensure Site Initiation Visits (SIVs) and site activations are achieved as planned.
- Attends and/or supports SIVs.
- Helps SSE-PL/SSE-SL in tracking resolution of any follow-up item needed post SIV until resolved by site and or CRO/Takeda study team.
- As invited, attends Investigator Meetings (in the region) and liaises with sites / CRO.
Enrollment and Study Conduct Phase
- Supports recruitment strategy and activities when targets are not met (e.g. utilization of Patient Recruitment & Retention materials, booster visits, phone contacts).
- Interacts closely with local CRO team throughout the lifecycle of the study.
- Helps coordinate and/or attends the SSE booster visit requested by SSE-PL/SSE-SL.
- Regularly interacts with priority sites in assigned trials.
- Helps to maintain study specific trackers (booster visits) as needed or requested.
Training
- Applicable local regulations
- SOP trainings (Takeda and CRO, as applicable)
- TA/Study specific training
You are expected to comply with internal guidelines and utilize company-provided tools, for applicable tasks and reporting.
Non-Study Specific Engagement Activities
Participation in following activities may vary depending on assignment by Line Manager
SSE Study Lead for Assigned Programs
- Helps to develop the global Site Engagement Strategy for the assigned trial, adapting it as necessary to meet specific requirements of each country.
- Attends program and study level meetings, as applicable, and provides relevant updates to SSE team members.
- Attends kick-off meetings, investigator meetings (in region).
Development of Strategic Site Relationships
- May be responsible for developing and maintaining long-term strategic relationships with selected sites/site networks to improve the site and Takeda experience.
Conferences, Congresses, Other Site Facing Events
- May be tasked to help the Associate Director, Study Site Engagement with developing and executing the SSE strategy for non-study specific activities within their designated Therapeutic Area (TA) or Country.
- Through participation in conferences or congresses, utilizes these key site-facing events to connect with sites beyond their physical locations. This role involves engaging with new clinical trial investigators or those unfamiliar with Takeda, thereby promoting support for the advancement of our pipeline.
Dimensions and Aspects
Technical/Functional (Line) Expertise
Understanding of clinical trials and advanced knowledge of ICH-GCP, Clinical trials regulations, and applicable global and regional/country requirements.
Decision-making and Autonomy
Able to make sound decisions after identification of an issue and being able to make careful consideration of various courses of action towards resolution. Considers the short and long-term impact of those decisions in terms of risk to Takeda from a regulatory, legal, financial and business acumen perspective. Influencing and motivational skills are needed for tactful and business smart communication with key internal- and external stakeholders.
Interaction
Regularly interacts with internal and external stakeholders. Key stakeholders for this role include but are not limited to Takeda Clinical Operations, Takeda Clinical Study Start-up and Engagement (CSSE) functions, Takeda Clinical Science, Takeda Medical Affairs, local R&D functions, site and CRO personnel.
Innovation
Foster enhanced site engagement by executing the global engagement strategy. Utilize innovative thinking to overcome obstacles and achieve goals.
Complexity
Possesses inter-cultural competencies and ability to work cross-functionally in a complex global organization.
Education & Competencies (Technical and Behavioral)
Education
Bachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required. A clinical or advanced degree (BSN, MS, MA, MBA, PharmD) is preferred.
Experience
7+ years of experience in clinical research, either with a CRO or a pharmaceutical company, focusing on clinical trials. Experience may also include roles such as Study Coordinator or Study Nurse, where close collaboration with Clinical Research Associates was involved. While experience in a Lead CRA or managerial role is preferred, it is not mandatory. The total cumulative work experience of the candidate may also be taken into consideration. Experience in Oncology clinical trials is preferred.
Essential Qualifications
- Extensive site management and/or monitoring experience across a range of highly complex disease areas
- Demonstrated capability of effective site oversight
- Solid knowledge of clinical development processes with strong emphasis on site management
- Ability to lead, troubleshoot and influence for quality and delivery
- Proven experience in effectively communicating with site staff including KOLs
- Experience in all study phases and in multiple indications preferred
- Comprehensive and current regulatory knowledge, including GCPs
Additional Skills
- Good organizational skills and ability to deal with competing priorities
- Effective communication skills (written, verbal in English and local language)
- Creative thinker, curious and unafraid to ask questions
- Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve
- Proficient with MS Office Suite (Excel, Word and PowerPoint).
Additional Information
- Demonstrates flexibility in schedule and willingness to travel frequently (at least 30% and as high as 50% during busy periods).
- Due to the location of the LOC and national/international travel, the following locations are recommended: Australia: Sydney (preferred), Melbourne, and Brisbane acceptable.
- On average, monthly LOC visits to meet with Medical/local teams