ROLE RESPONSIBILITIES Responsible for relationship building and management
- The Site Relationship Partner is the main Pfizer point of contact for investigative sites, responsible for building and retaining relationships from site activation through the lifecycle of studies.
- The Site Relationship Partner is the "face of Pfizer" and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and Pfizer's reputation is that of "Partner of Choice."
- The Site Relationship Partner proactively collaborates and provides local intelligence to country outreach surveys, targeted sites strategies, study design, and Pfizer pipeline opportunities.
- The Site Relationship Partner 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 Site Relationship Partner will help coordinate with other roles and functions that will interface with target sites, thereby, simplifying site Pfizer communications and enhancing overall visibility into and confidence of quality of site-level activities.
Responsible for proactively providing local intelligence
- 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.
- Act as the main point of contact for all site- and study-level questions, liaising with and escalating to appropriate teams to respond and resolve questions.
- Follow up and close issue status with investigators to ensure awareness of resolution.
- Inform and educate investigator sites of Pfizer pipeline opportunities that may be a good fit.
- Lead effective site recruitment planning and implementation of plans at the country- and site-level, consistent with global plan and local targets.
- Demonstrate leadership within the local clinical development environment with a goal to enhance Pfizer reputation in scientific leadership.
Accountable for study start-up, activation, and execution to plan;For targeted sites
- Provide country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices.
- Provide country/regional level input to country strategy, feasibility and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required.
- Apply clinical development strategy in the assessment of country and site selection at the asset level.
- Provide country/regional level input to country strategy/planning and site recommendation through intimate understanding of country, sites, processes and practices, and associated site performance metrics.
- Provide input to cluster level intelligence for site strategy and support implementation of cluster-level strategy.
- Review and manage site practices that differ from Pfizer practices and liaise with study teams and study management.
- Understand targeted site criteria as well as services delivered to target sites. Track that all such services are provided consistently and in a timely manner.
- Recommend potential targeted sites and conduct follow up with those sites as required.
- Develop a solid understanding of targeted site-specific/institution-specific requirements to apply this knowledge to future site activities or the development of new targeted site relationships.
For all sites:
- Deploy GSSO targeted site strategy by qualifying and activating targeted sites, while coordinating Pfizer functions to standardize processes and deliver activation in line with the targeted site strategy.
- Confirm (and educate where needed) that sites are familiar with Pfizer requirements for study start up and facilitate the availability of MSAs when feasible.
- Lead study start up activities at the site level, including management of issues that may compromise time to site activation.
- 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.
Responsible for CRO and Study Management Interface
- 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.
- Maintain a thorough knowledge of assigned protocols.
- Proactively identify, manage and escalate site issues related to study delivery, triaging and coordinating communications and resolution efforts by Pfizer colleagues.
- Support database release by facilitating query resolution, as needed.
- Actively pursue possible efficiencies and develop best practices in the delivery activities for site start up and performance at the targeted site level to increase investigator/site satisfaction and strengthen targeted site relationships with Pfizer.
- Seek assignment to complex protocols due to demonstrated capability in responsibilities.
BASIC QUALIFICATIONS Training and Education
- Support local CRO representatives develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Site Excellence Partner and Study Management.
- The Site Relationship Partner may be required to support some or all of the primary responsibilities of the Site Excellence Partner, 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 Site Relationship Partner may be required in identifying CRA performance issues and responsible for ensuring appropriate corrective and preventative actions are put in place.
- 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 + 7 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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- 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, GCP, 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.
Other Job Details:
- The role will be expected to travel to sites within the Northeast region (Maine to Washington D.C.).
- Last Date to Apply for Job: November 1st, 2021
- Eligible for Employee Referral Bonus: YES
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