Study Operational Manager

ROLE SUMMARY

The Study Operations Manager is responsible for study and regional/country level activities from study startup through conduct and study close.  The Study Operations Manager will be assigned one or more studies and will be tasked with taking on several responsibilities in support of the larger Study Management deliverables. The Study Operations Manager partners with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Country Trial Manager, Site Excellence Partners, Site Relationship Partners, Site Care Partners, Contracts Lead, Regulatory Affairs, pCRO and others as required to ensure a coordinated approach to study start up, execution and close out.

The Study Operations Manager has exceptional knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team.  The Study Operations Manager provides leadership and strategic planning and organization skills to ensure the operational delivery of tasks within one or more studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable. The Study Operations Manager may be responsible to independently take on the closing out of one or more studies post database lock.  Provides back up to or takes on the responsibilities of Global Study Manager as needed.

Accountable for the execution of tasks and developing solutions to problems as needed to support deliverables.  The Study Operations Manager will be fully accountable and responsible for tasks as designated on the study by the Global Study Manager which may include:

• Regional/Country/Study level implementation of Startup and Site Activation Plans (through SUPM or pCRO if assigned)
• Regional/Country/Study level Recruitment Strategy
• Responsible for development of study level plans
• Communication with internal stakeholders and pCRO as applicable and as listed above to ensure efficient and timely study delivery of the agreed plans
• Responsible for study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
• Responsible for ensuring the follow up and coordination of Regional/site QEs, PDs, data issues, metrics review, site issues/risks, audit responses, etc.
• The Study Operational Manager will be able to work independently and exercise their own judgement and be a resource for others.

BASIC QUALIFICATIONS

Training and Education 

• Extensive operational clinical trial experience
• A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology
• BA/BS + strong relevant experience
• MBA/MS + strong relevant experience
• Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
• English is required.

Prior Experience 

Experience

• Demonstrated clinical research experience and/or study management/startup project manager experience
• Demonstrated knowledge of site selection, site activation, site readiness interdependencies
• Demonstrated knowledge of clinical trial methodology and the drug development process
• Demonstrated experience participating on cross functional teams
• Demonstrated experience in Project Management and Quality Management
• Demonstrated experience in a matrix management environment

Skills and Technical Competencies

• Expertise in the use of study/site dashboard and reporting tools
• Detail oriented & possesses technical expertise
• Ability to manage complex processes
• Ability to manage in a matrix environment
• Risk Identification & Mitigation
• Strategic Planning, Analytical and Problem-Solving Skills
• Critical Path Analysis
• Excellent communication skills, both written and verbal
• Ability to adapt to changing technologies and processes
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization 

PREFERRED QUALIFICATIONS

Skills

Behavioral Competencies

• Requires exceptional knowledge of own discipline and advanced knowledge of others and applies these skills to ensure a Sub Business Uni t/Sub Operating Unit meets its goals
• Creates an environment where innovation is standard taking appropriate risks to advance innovative processes
• Develops ideas and leads complex projects across Sub Business Unit/Sub Operating Unit
• Develops innovative solutions to complex problems impacting a Sub Business Unit/Sub Operating Unit
• Exercises own judgment and is a resource for others.  Works independently with assignments often self-initiated

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Travel may be required, including Investigator Meetings, Vendor Kick Off Meetings and Vendor Re-set Meetings.  In addition, may also expected to travel to global-GSSO or department-level meetings.

  May be required to work outside of core business hours to support global trials or initiatives.

  #LI-PFE

Purpose 

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.  

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility  

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!  

Equal Employment Opportunity 

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

Medical#LI-Remote #LI-PFE