Clinical Trial Manager

Pfizer Boulder , CO 80301

Posted 3 months ago

This position resides in our Boulder, CO or Morrisville, NC offices and will be responsible for leading the execution of oncology clinical studies to required quality standards, on schedule and on budget. This is an office-based position


  • Oversees the delivery of studies to ensure that they are completed on time, within budget and in compliance with SOPs, FDA and global regulations and ICH/GCP guidelines

  • Provides Clinical Operations leadership to CROs, other vendors, CRA team, internal study team, and Project Coordinators

  • Develops timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines

  • Responsible for developing and implementing robust contingency and issue management plans to solve complex issues that impact study or program milestones

  • Manages staff and provides technical advice to team members

  • Disseminates clinical study communications to all functional groups and leads study and team meetings

  • Interacts with clinical research investigators and sites

  • Interacts with Senior Management to report on progress of milestones

  • Organizes, attends, presents and provides training at investigator meetings

  • Assists or leads development and writing of study protocols, study plans, CRFs, informed consent forms, study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA)

  • Travel required: up to 20%


BA/BS or higher degree

  • Recent oncology experience in the last 3-5 years required

  • 5+ years' experience in clinical study or program management, including study start-up, conduct, and close-out of trials (level determined by experience)

  • Solid technical knowledge of oncology therapeutic area required

  • Experience in oversight and management of Clinical Research Organizations (CROs), central laboratories, and other vendors required

  • International trial management experience desired

  • Phase I study management experience desired

  • Demonstrated ability to develop operational strategy for clinical studies, including development of timelines, communication plans, risk management/contingency plans and budgets

  • Line and matrix management experience preferred

  • Expert knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations

  • A strong communicator with excellent verbal and written communication skills

  • A highly collaborative person who is able to respond to constantly changing circumstances and needs

  • Strong leadership skills, with demonstrated project or program management

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.


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


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr Clinical Research Specialist

Medtronic Inc.

Posted 7 days ago

VIEW JOBS 1/10/2020 12:00:00 AM 2020-04-09T00:00 Location: Boulder, CO Careers That Change Lives Impact patient outcomes. Come for a job, stay for a career. Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market. Bring your talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentoring, and guidance you need to own your future success. Join us for a career that changes lives. In this exciting role as a Sr. Clinical Research Specialist (CRS) you will have primary focus responsibility to work closely with Medical and Clinical Affairs leadership, Research & Development, and Product Marketing and Market Development personnel in the development and execution of clinical studies for the Patient Monitoring division of the Respiratory, Gastrointestinal and Informatics (RGI) strategic Business Unit of Medtronic. MITG The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions. RESPIRATORY, GASTROINTESTINAL & INFORMATICS (RGI) offers a complete line of solutions that spans the continuum of care. We help with early detection and treatment of diseases, and reduce complications to accelerate recovery from patient conditions. We focus on expanding global access to our therapies that improve clinical outcomes for gastrointestinal diseases and cancer, and patients with respiratory compromise. A Day in the Life Responsibilities may include the following and other duties may be assigned. * Oversees, designs, plans and develops clinical research studies. May be involved in early study development including statistical design of the trial. * Prepares and authors protocols and patient record forms. * Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. * Assists in Overseeing and interpreting results of clinical investigations in preparation for new drug device or consumer application. * Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and may prepare clinical trial budgets. * Oversees clinical study operations, including safety, monitoring, data management, and site and vendor selection. * Builds and maintains optimal relationships and effective collaborations with various internal and external parties. * Escalates any study issues quickly to leadership and ensures study milestones are met. * Maintains understanding of regulatory requirements across multiple regions; serves as resource for clinical strategy personnel. * May represent Clinical Affairs team on certain product core teams providing SME support with clinical requirements in accordance with SOPs and regulations. Other Responsibilities: * Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and management. * Reviews status of projects and budgets; manages schedules and prepares status reports. * Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives. * Develops mechanisms for monitoring project progress and for intervention and problem solving * Present to and partner with clinical leadership on the overall health of the portfolio, successes, and areas of opportunity. * Organizational Impact: May be responsible for entire projects or processes within job area. * Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. * Makes improvements of processes, systems or products to enhance performance of the job area. * Analysis provided is in-depth in nature and often provides recommendations on process improvements. * Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making. Must Have (Minimum Requirements): To be considered for this role, the minimum requirements must be evident on your resume. * Bachelor's degree required with a minimum of 4 years of clinical research experience or advanced degree with a minimum of 2 years of clinical research experience Nice to Have (Preferred Qualifications): * Degree in engineering, life sciences, or related medical/scientific field. * Clinical Research experience at Medtronic or within a medical device industry. * Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials. Ability to incorporate and adhere to good clinical practices and regulatory standards. * Experience managing multiple clinical research sites with proven results in study execution. Ability to identify and implement solutions in addressing study issues. * Excellent project management and data management process skills. * Basic understanding of biostatistics and trial design. * Experience working on a global study team. * Experience in managing clinical trial data review. * Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications. Competencies: * Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. * Communication and Influence: Communicates with senior internal and external customers and vendors. * Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. * Ability to establish priorities independently and work under tight deadlines * Demonstrates desire to learn and shows initiative * Excellent project management and organization skills. * Works independently under limited supervision to determine and develop approach to solutions. * Coaches and reviews the work of lower level specialists; may manage projects/processes. About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America) Ability to travel 10-25%. Check out Medtronic Inc. Boulder CO

Clinical Trial Manager