8 days old

Site Relationship & Excellence Manager ( 1 Year Contract)

Pfizer
Istanbul
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**JOB RESPONSIBILITIES**



+ Usher investigator sites through site activation and study activities from study start up to close out.

+ Lead effective site recruitment planning and implementation of plans at the country- and site-level, consistent with global plan and local targets.

+ 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.

+ Recommend potential targeted sites and conduct follow up with those sites as required.

+ 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.

+ 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.

+ Support database release by facilitating query resolution, as needed.

+ Seek assignment to complex protocols due to demonstrated capability in responsibilities.

+ 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.

+ Responsible for site and monitoring quality, regulatory and GCP compliance.

+ Drive inspection readiness and provide support for site audits/inspections as needed, following through audit/inspection finding to resolution.

+ Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation

+ Leads in conjunction with local country intelligence to to proactively identify risks. Lead risk assessment at the site/country level for their studies, including identifications of mitigation and control.

+ Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.). Demonstrate use of data to enhance quality and accelerate study delivery.

+ Apply knowledge of data and analytics to target site and study, recommend and implement actions for mitigation and control.

+ Conduct and report oversight activities, both remote and onsite visits, according to Pfizer requirements and standards.

+ Work with CRO CRAs, and other CRO colleagues as appropriate, to drive resolution of oversight issues.

+ Accountable for identifying site and CRA performance issues and quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of CAPAs to address these.

+ Demonstrates the learning culture by ensuring site quality and trends, including preventive actions are shared across study & assets in the portfolio to drive accelerated drug delivery.

+ Identify potential improvements for Pfizer processes.

+ Review of monitoring visit reports.

+ Serve as key contributor to process improvement initiatives and may lead local area initiatives.

+ Act as a Subject Matter Expert for a category or global processes within the GSSO organization.

+ Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality.

+ Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements.

+ Support local Investigator relationship management with the Site Relationship Partner.

+ Serve as point of contact for quality and safety escalations for CRO, CRAs, Site Relationship Partner and Study Team.



**QUALIFICATIONS / SKILLS**



+ 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.

+ Solid knowledge of clinical development processes with strong emphasis on monitoring

+ Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance (preferred)

+ Site Management/Monitoring (CRA) experience (preferred)

+ Project management experience preferred in the clinical development area

+ 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 ability to manage projects and cross-functional processes

+ Ability to evaluate, interpret and present complex issues and data to support assessment and mitigation of site risk

+ Seeks to develop an integrated view of key colleague issues to shape decisions and strategy development

+ Effectively overcoming barriers encountered during the implementation of new processes and systems

+ Builds wide networks and alliances; utilizes stakeholder input to develop strategic thinking and find opportunities for collaboration

+ Considers stakeholders including regulatory agencies and marketing when developing strategies and future directions

+ Acts as a champion of change across the area/region/countries; uses facts, logic and personal credibility to influence the successful implementation of process improvements

+ Exhibits behaviors consistent with company values to colleagues at multiple locations with diverse cultures

+ Availability to travel regularly within country and region is required



\#LI-PFE



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Medical
Posted: 2020-11-16 Expires: 2020-12-17
Sponsored by:
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Site Relationship & Excellence Manager ( 1 Year Contract)

Pfizer
Istanbul

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