Manager, Clinical Data Scientist, Clinical Data Sciences

Use Your Power for Purpose

As part of the Clinical Data and Information Sciences (CDIS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Clinical Data Scientist is responsible for representing CDIS at the study team level. The Clinical Data Scientist is accountable for the coordination of all CDIS deliverables associated with a clinical trial, as well as adherence to data standards and the quality of the study data sets. The Clinical Data Scientist provides leadership, direction, and oversight to Data Managers working on the clinical trial and is accountable for the trial’s inspection readiness.

What You Will Achieve

In this role, you will:

• Serve as Clinical Data Scientist for one or more clinical trials, assuming responsibility for all CDIS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence.

• As a member of the Core Study Team, drive operational excellence in collaboration with cross-functional partners through the application of CDIS best practices at the study level; serve as technical resource on how to best collect, process, consume and report clinical trial data.

• They are accountable for the quality and timeliness of all CDIS deliverables in support of the clinical trial; They partner with Research/Business Units, external data/service providers and internal CDIS staff to deliver high quality data management for all studies as assigned.

• Proactively drives quality and efficiency to meet study/asset timelines milestones, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team.  Ensure work carried out by/on behalf of CDIS is in accordance with applicable SOPs and work practices; accountable for assuring adherence to regulations, standards, GCDMPs, ALCOA principles by the team they are coordinating.

• Ensure the required study-specific CDIS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously.

• Work with Asset Leads to establish strategy, timelines, and adequate resourcing of the study.

• Provide leadership, direction and oversight to the CDIS resources working on the clinical trial(s).

Here Is What You Need (Minimum Requirements)

• Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review  Strong project and risk management

• Proven Clinical Data Management experience required

• Strong verbal and written communication skills

• Consistent, detail oriented, communicative, dedicated to excellence

• CRO and vendor oversight experience preferred

• Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements

• Proficiency with commercial clinical data management systems and/or EDC products (e.g. Medidata RAVE, Oracle RDC / InForm, etc.)

• Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, JReview)

• Familiarity with MedDRA/WHO-Drug

• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, PowerPoint, etc.)

• Bachelor’s degree required. Degree in scientific field preferred. Master’s degree preferred.

Work Location Assignment: Remote

The closing deadline for applications is September 21st.

All applicants must have the relevant authorisation to live and work in the UK.

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!