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Trial Optimization Lead


Groton, CT
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Job Details


Capitalize on the foundation of knowledge in the areas of Pfizer historic study performance data, competitor trial performance, real world data, and industry benchmarks using a variety of analytic and modeling tools such as DecisionView StudyOptimizer (DVSO) and goBalto Activate and Analyze. Provide Feasibility Leads with timely up-to-date information and intelligence on decision making data elements in support of the OpCo governance process. Support the development of more consistent and accurate study timeline and enrollment projections that drive study team decision making and enhance predictable delivery of the portfolio.


+ Extensive working experience in goBalto Activate or a similar workflow solution.

+ Experience in accelerating clinical study start up. Solid understanding of the workflows involved in site selection, IRB/IEC submissions/approvals, site essential document processing, contract and budget negotiations, and enrolling the first subject.

+ Demonstrated expertise in Configuration Designer functionality in goBalto Activate or configuration functionality in a similar country workflow solution. Responsible for all country configurations/validations and the country configuration change management process.

+ Understanding of goBalto Analyze or similar workflow reporting module to provide real-time visibility into study startup processes utilizing analytics and dashboards.

+ Provide Activate Subject Matter Expertise and training to internal and external system users and study team stakeholders. Ensure consistent utilization of Activate for startup planning and reporting

+ Support Feasibility Leads in establishing data driven startup and enrollment projections throughout the development lifecycle from asset planning through study initiation to completion of study enrollment

+ Drive proactive risk mitigation through data driven startup and enrollment scenarios utilizing internal and external data sources

+ Ensure effective scenario generation and planning comparing Pfizer's past performance data and proposed scenarios from CROs

+ Ensure data driven enrollment scenarios are presented in a standardized format

+ Operates effectively in a highly matrixed environment

+ Maintain relationships with providers/vendors of innovative capabilities in startup, feasibility, scenario planning and protocol optimization

+ Routinely review enrollment plans of ongoing studies in support of portfolio priorities

+ Participate in the establishment of systems and processes that support early startup and feasibility by leveraging existing data sources and organizational knowledge/expertise

+ Contribute to the establishment and delivery of feasibility analytics and metrics against an agreed upon set of KPIs/goals

+ Influences alignment of business strategies that promote the widespread implementation of suitable clinical trial technologies supporting Study Optimization startup and feasibility analytics and early planning

+ Maintain connectivity to Pfizer portfolio and clinical trial pipeline to ensure information and intelligence on indications of interest are available in a timely manner.

+ Promotes a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity


+ A broad based experience in clinical research is preferred. Knowledge of GCP and a good understanding of the processes associated with study start up, feasibility and enrollment planning.

+ History of success in a customer service role with a demonstration of meeting customer expectations.

+ Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization

+ Knowledge of drug development and a thorough understanding of the processes associated with feasibility, clinical study start-up and business operations

+ In general, candidates for this job would have the following levels of experience:

+ BS/RN/-10 years

+ MS - 8 years

+ PhD/MD - 4 years

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**Additional Details:**

+ Eligible for Employee Referral Bonus

+ This job is Pfizer Exempt US/PR Grade: 12

+ Pfizer UK Grade TBD

+ Additional Location Information: Sandwich, GBR, Walton Oaks, GBR, Remote-GBR, La Jolla, CA, New York, NY, Collegeville, PA, Peapack, NJ, Remote-NJ

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