Study Operations Manager (m/f/d)

at  Pfizer

Home Office, Nordrhein-Westfalen, Germany -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate23 Jan, 2025Not Specified23 Oct, 2024N/AGood communication skillsNoNo
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Description:

A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Right now, we are seeking highly qualified candidates to fill the position:
Study Operations Manager (m/f/d)

About the role:

  • You will have responsibilities for study and regional or specific country level activities from study startup through conduct and study close.
  • You will have responsibility for study management aspects of assigned studies of limited complexity (e.g. single country, a small number of countries/sites) or manage a unique part of a larger study (e.g. recruitment and retention).
  • You will be assigned to one or more studies and will be tasked with taking on responsibilities in support of Global Study Managers, other Study Operational Managers and the larger Study Management delivery of the study.
  • You may partner with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Country Trial Manager, Site Care Partners, Site Excellence Partners, Site Relationship Partners, Contracts Lead, Regulatory Affairs, pCRO and others as required to ensure a coordinated approach to study start up, execution and close out.
  • You help guide the Study Management strategy by inputting local intelligence and providing accurate updates on tasks delegated to them in order to support establishment of critical path activities and risks.
  • You will ensure the operational delivery of responsible 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.

About You:

  • You hold a scientific or technical degree
  • You have relevant operational clinical trial experience and very good knowledge of clinical trial methodology
  • You have working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
  • You have project manager experience and demonstrated experience in managing country level operational activities and/or vendors
  • You have fluent English language Skills, German language skills are a plus

Together we stand for:
Breakthroughs that change patients’ lives – In order to fulfill our corporate purpose, a value-oriented corporate culture guides our actions. Pfizer’s values are: Courage, Excellence, Equity & Joy.
Courage: One bold way we are achieving our goals is our company-wide digital transformation strategy. Our flat hierarchies enable short decision-making paths.
Excellence: We focus on what is really important, take responsibility, measure progress and work together in a spirit of trust. Together we rely on an agile way of working that encourages our employees to balance their private and work lives and to promote personal development.
Equity: We believe that different experiences are valuable, which is why every opinion is heard and valued. These experiences and opinions enrich the entire company. In this way, we promote a diverse and inclusive working environment in which colleagues in various Diversity, Equity & Inclusion (DE&I) working groups such as, e.g. Engage Empowered Women, LGBT*IQ , DisAbility, X-Gen.
Joy: If we experience our work as meaningful, we get a lot in return. We achieve this by being proud of the contribution we make, appreciating each other and sharing this with joy and recognition. Our BRAVO Award program gives us an appreciative opportunity to do so. Our employees benefit from a comprehensive company health management “Pfizer in Balance” also during working hours.
Living our values extends well-beyond the workplace, you get the opportunity to support people in need and to carry out our efforts around diversity, inclusion & equity, environmental sustainability and against any form of exclusion through volunteering e.g., during our annual engagement days.
For us, it goes without saying that we offer fair remuneration in accordance with the IG BCE framework collective agreement, as well as a pension scheme and many other attractive benefits.
Visit our website for more Information at:
Arbeiten bei Pfizer Deutschland

Responsibilities:

  • You will have responsibilities for study and regional or specific country level activities from study startup through conduct and study close.
  • You will have responsibility for study management aspects of assigned studies of limited complexity (e.g. single country, a small number of countries/sites) or manage a unique part of a larger study (e.g. recruitment and retention).
  • You will be assigned to one or more studies and will be tasked with taking on responsibilities in support of Global Study Managers, other Study Operational Managers and the larger Study Management delivery of the study.
  • You may partner with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Country Trial Manager, Site Care Partners, Site Excellence Partners, Site Relationship Partners, Contracts Lead, Regulatory Affairs, pCRO and others as required to ensure a coordinated approach to study start up, execution and close out.
  • You help guide the Study Management strategy by inputting local intelligence and providing accurate updates on tasks delegated to them in order to support establishment of critical path activities and risks.
  • You will ensure the operational delivery of responsible 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


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Hospital/Health Care

Pharma / Biotech / Healthcare / Medical / R&D

Health Care

Graduate

Proficient

1

Home Office, Germany