Inclusively is partnering with a pharmaceutical and biotechnology corporation to hire a Manager, Clinical Data Scientist, Clinical Data Sciences. **Please note: this role is NOT an internal position with Inclusively but with the partner company.**

ABOUT INCLUSIVELY:

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POSITION SUMMARY

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Clinical Data Scientist (CDS) is responsible for timely and high quality data management deliverables supporting the company portfolio. The CDS delivers asset level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization of the company portfolio and further precision medicine. The CDS designs, develops, and maintains key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, applies standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data.

KEY RESPONSIBILITIES

• Serve as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all CDS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence
• Serve as a technical resource to the study teams for DM and RBM standards, tools, data provisioning, and reporting
• Partners with Research/Business Units, external DM service providers and internal CDS staff to deliver high quality data management for all studies as assigned.
• Proactively drives quality and efficiency to meet timeline and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team (s).
• Ensure work carried out by or on behalf of CDS is in accordance with applicable SOPs and working practices.
• Participates and ensures quality database design including documentation, testing and implementation of clinical data collection tools, both CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.
• Ensure the required study-specific CDS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously.
• Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity monitoring, data cleaning, e-data processing, data access and visualization, and database release.

MINIMUM QUALIFICATIONS

• Demonstrated successful experience in all relevant clinical data management activities in a BioPharmaceutical or CRO setting
• Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review
• Strong Project and Risk Management
• CRO and vendor oversight experience preferred
• Minimum 5 years Data Management experience required
• Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
• Proficient experience using commercial clinical data management systems and/or EDC products (Oracle RDC / Inform preferred)
• 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
• Bachelor’s degree required. Degree in scientific field preferred.

PREFERRED QUALIFICATIONS

• Master’s degree preferred.

PHYSICAL/MENTAL REQUIREMENTS

• Primarily an office-based position involving sitting, walking to meetings, making presentations, etc.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Ability to travel approximately 5 to 10%

Work Location Assignment: Hybrid

The annual base salary for this position ranges from $93,500.00 to $155,900.00.* In addition, this position is eligible for participation in our Global Performance Plan with a bonus target of 12.5% 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 company Matching Contributions and an additional company 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. Our 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.

* The annual base salary for this position in Tampa, FL ranges from $84,200.00 to $140,400.00.

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