Study Manager 1 (Manager)

Pfizer Groton , MA 01450

Posted 3 weeks ago

Why Patients Need You

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will Achieve

You will be part of Pfizer's medical team and manage the clinical studies. Your project management skills will be leveraged for planning, directing, creating and communicating timelines. You will ensure that the clinical studies are within time, budget and scope.

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your problem solving ability and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the division.

  • Oversee the overall execution of clinical studies and be accountable for the development of realistic detailed study startup and monitoring plans.

  • Oversee and support study start up activities at the country level, including review of key documents and providing support to address regulatory and/or ethics committee questions. Forecast and manage the Clinical Trial Budget.

  • Manage full studies for Operational Study Management or manage a unique part of a larger study.

  • Serve as primary point of contact for study decisions related to the protocol, data collection and volunteer activities.

  • Approve and oversee drug supply management and manage flow of drug supply to the sites.

  • Partner with key team members to manage the program to achieve key milestones within time, cost and quality parameters.

  • Work with functional lines and directly with Contract Research Organization (CRO) line functions to resolve or triage site level issues.

  • Share and escalate plan deviations to Clinical Project Manager and study team.

  • Help to address Significant Quality Events or other quality issues at patient and/or site level.

  • Lead the data integrity and data quality activities for assigned protocols.

  • Provide regional and cross-regional insights on study-site performance and trends to /from the study team.

Qualifications

Must-Have

  • Bachelor's Degree

  • 5+ years' experience

  • Demonstrated project management / leadership experience.

  • Experience working in the research and development of pharmaceutical industry.

  • Experience conducting, managing or participating in regulatory inspection processes.

  • Knowledge of project management discipline and its application to vaccine development.

  • Country level cultural awareness and strong interpersonal skills.

  • Excellent communication skills, both written and verbal in English.

Nice-to-Have

  • Master's degree

  • Experience in early drug development.

  • Knowledge of the project management discipline and its application to vaccine/drug development.

Other Job Details:

  • Last Date to Apply for Job:

  • Eligible for Employee Referral Bonus:YES

#LI-PFE

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.

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.

Medical

#LI-PFE

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Study Manager 1 (Manager)

Pfizer