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Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people with heart.

FSP - Site Relationship Partner

Job ID 72746BR Argentina - Any Region - Home Based
About ExecuPharm
ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

Job Title: Site Relationship Partner (SRP)
Position Purpose:
• The Site Relationship Partner (SRP) is the main Client point of contact for investigative sites, responsible for building and retaining relationships from site activation through the lifecycle of studies
• The SRP is the face of the Client and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and the Client’s reputation is that of Partner of Choice.
• The SRP proactively collaborates and provides local intelligence to country outreach surveys, targeted sites strategies, study design, and Client pipeline opportunities
• The SRP is accountable for study start up, activation, and execution to the plan for targeted sites.
• In addition to being the main point of contact, the SRP will help coordinate with other roles and functions that will interface with target sites, thereby, simplifying site Client communications and enhancing overall visibility into and confidence of quality of site-level activities
• The SRP may be required to support some or all of the primary responsibilities of the Site Excellence Partner (SEP), as example, safeguarding the quality and patient safety at the investigator site, responsible for site and monitoring oversight, and utilizing and interpreting data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks
• Additionally, the SRP may be required in identifying Clinical Research Associate (CRA) performance issues and responsible for ensuring appropriate corrective and preventative actions are put in place

Primary Duties:
Responsible for relationship building and management
• Usher investigator sites through site activation and study activities from study start up to close out.
• Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback
• Lead effective site recruitment planning and implementation of plans at the country- and site-level, consistent with global plan and local targets
Responsible for proactively providing local intelligence
• Provide country/regional level input to country outreach surveys including protocol feasibility, country Standard of Care (SOC) and medical practices
Accountable for study start-up, activation, and execution to plan
• For targeted sites
o Lead study start up activities at the site level, including management of issues that may compromise time to site activation
o Closely monitor and support study start up activities including review of key documents (e.g., local Informed Consent Document template), to address regulatory and/or ethics committee questions for targeted sites
• For all sites
o Provide enrollment support and ensure progress by responding to start up and recruitment issues from investigators, partner with study team to define and support recruitment initiatives at site / country level
o Proactively identify, manage and escalate site issues related to study delivery, triaging and coordinating communications and resolution efforts by Client colleagues
o Support database release by facilitating query resolution, as needed
• Responsible for CRO and Study Management Interface

Qualifications

Skills and Education:
• A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology
• In general, candidates for this job would hold the following levels of education/experience: BS/BSc/MS/MSc or equivalent + 5 years of clinical research experience and/or quality management experience
• Skills in more than one language are an advantage in this role; English is required
• Experience with drug development and monitoring (preferred)
• Experience implementing centrally designed and developed initiatives on a local basis
• Demonstrated knowledge of quality and regulatory requirements for applicable countries
• Demonstrated knowledge of site intelligence at country/cluster level in support of site recommendation
• Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, Good Clinical Practice (GCP), Food and Drug Administration (FDA), or country-specific regulatory environment
• Demonstrated success in prior scientific/technical/administrative roles
• Demonstrated experience in site activation
• Demonstrated networking and relationship building skills
• Demonstrated ability to manage projects and cross-functional processes
• Ability to communicate effectively and appropriately with internal & external stakeholders
• Ability to adapt to changing technologies and processes
• Seeks to develop an integrated view of key colleague issues to shape decisions and strategy
development
• Proactively manages change by identifying opportunities and coaching self and others through the
change
• Demonstrated ability to introduce new ideas and implement them
• Effectively overcoming barriers encountered during the implementation of new processes and systems
• Identifies and builds effective relationships with customers and other stakeholders
• Works well across country boundaries, respecting communication and cultural differences in interpersonal relationships
• Availability to travel regularly within country and region is required
• Effective verbal and written communication skills in relating to colleagues and associates both inside
and outside of the organization

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