Director of Site Management and Monitoring (DSMM)

POSITION SUMMARY

Supporting Pfizer Oncology, in partnership with the Director of Clinical Site Operations (DCSO), you will ensure appropriate Site Care Partners (SCP) are in place to deliver on, country and site-level end to end study start up, site management and monitoring activities in-line with study milestones for the United States, as well as providing line management and overseeing the job function of the Site Care Partner.  You will support the DCSO, who is responsible for ensuring overall operational site management and oversight activities within the United States and supervising the activities of sites to ensure patient safety and quality of study execution in accordance with applicable prevailing laws, Good Clinical Practice, and Pfizer standards. You will partner cross functionally with others in Study Start Up (Start Up Project Management (SUPM), Site Activation Partner (SAP), Clinical Trial Assistant (CTA), Investigator Contracts Lead (ICL), Site Monitoring, Optimization, Analytics, and Recruitment Solutions (OARS), Patient Recruitment and Study Management to provide input to country and site selection and collaborate with country regulatory/regional Clinical Trial Regulatory Operations (CTRO) to facilitate Clinical Trial Application/IRB/EC approval for allocated studies in the United States when applicable. You will also execute investigator site/recruitment strategies and site-level end to end study start up, site management and monitoring activities. You will also lead, contribute to, and implement strategic initiatives as a representative of the Global Site and Study Operations (GSSO) Leadership. You will also lead initiatives that shape the clinical development environment within the United States to facilitate Pfizer’s clinical development goals and scientific leadership.

POSITION RESPONSIBILITIES

• Line Management of Site Care Partner roles (Team size approximately 15 colleagues and Functional Service Providers-FSP)

• Lead and coach allocated resources within assigned country/cluster/region.

• Overall accountability for the Growth and Development of the Site Operations organization  

• Oversee job function as described in the Site Care Partners & Line Manager of SCPs job description and ensure compliance with training requirements.

• Closely liaise with the FSP Manager of Site Care Partner as described in standard contracts with the FSP organization to oversee FSP SCP roles’.

• Where required, perform joint site visits with direct reports to assess performance.

• Demonstrate leadership in the resolution of site/country/cluster/regional issues to maintain site start-up, quality and solid investigator site relationships.

• Establish consistent direction and priorities across assigned countries/cluster/region.

• Responsible for country level input into country selection, pre-feasibility, study design and site identification and selection; when necessary, support and champion existing associated processes.

• Ensure that feedback on country/site decisions is effectively communicated to appropriate stakeholders.

• Demonstrate Therapy Area expertise, where appropriate.

• Responsible for timely and quality site start-up including activation.

• Mitigate systematic deficiencies in clinical trial conduct across sites, to improve quality and patient safety in selected investigational sites.

• Ensure sites with virtual monitoring and oversight capabilities are identified and enabled, as applicable.

• Share country/cluster/regional issues and trends with stakeholders (e.g., study/program teams, local Medical Affairs teams, local CROs, Medical Quality Assurance, etc.), as needed.

• Drive effective resource management across portfolio for given country to ensure balanced resource allocation for SCP across the Oncology Therapeutic Areas and regions.

MINIMUM REQUIREMENTS

• Relevant PhD and a minimum of 5 years of clinical research experience

• Relevant Masters degree and a minimum of 7 years of clinical research experience

• Relevant Bachelors degree and a minimum of 8 years of clinical research experience

• Extensive knowledge of clinical trial methodologies with experience delivering high quality clinical trials in a multi-national pharmaceutical company and/or clinical research organization.

• Experience leading and managing people and large, diverse teams in a matrix environment

• Experience engaging with senior stakeholders internally and externally to the organization.

• Experience working effectively with line support functions including Finance and People Experience (PX) across the region.

• Experience managing escalated issues from sites / investigators

• Availability to travel up to 20% within the country and/or globally as required. 

• Strong learning agility

PREFERRED QUALIFICATIONS

• Understanding of Pfizer People Experience (PX) procedures and policies at global and local level.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel within the country and/or globally

Work Location Assignment: Remote

The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Medical

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