Clinical Trial Specialist, Translational Medicine (Hybrid)

Job Description

Translational Medicine is responsible for early clinical development of novel therapeutics, working in close collaboration with Discovery Sciences and late-stage Clinical Research across all therapeutic areas. Our team is focused on innovation and dedicated to translating breakthrough science into innovative medicines that extend and improve the lives of patients worldwide. Through clinical trials, we ensure the safety and efficacy of our pipeline and existing products to produce safe, effective, innovative medicine.

The Clinical Trial Specialist partners with the early development clinical study team in the planning, execution, closeout and reporting activities for clinical trials and is accountable for delivering selected critical-to-quality tasks.

Primary Responsibilities:

• Focus on compliance, quality, timeliness and accuracy of trial and program deliverables, leveraging clinical expertise, project management and communication skills to ensure compliant, accurate and timely reporting (eg, milestone dates in the Clinical Trial Management System (CTMS), Trial Master File (TMF), Clinical Study Reports (CSR))

Partner with clinical team for site/CRO ready (planning) through trial closeout and reporting deliverables, including the following activities:

• Collection/approval of essential documents

• Systems provisioning and milestone data entry

• Drug and ancillary supplies management

• Clinical Study Report assembly, accuracy and quality control reviews

• Ensure timely and complete execution of trial level agreements and contracts (Confidentiality Disclosure Agreements (CDAs), consultant, vendors, trial level samples and services)

• Contribute to inspection readiness with expertise and knowledge of global/local regulations, GCP, and ICH guidelines

• Detect and resolve quality issues, escalating to clinical scientist or consulting other functions (eg, Quality, Legal, Compliance, etc.) to arrive at the best solution

• Report, manage, and interpret information for clinical trials to ensure completeness and accuracy across multiple business systems and tools (ESTAR-Early Stage Trial Tracking & Reporting, TMF, CTMS, REDS)

Position Qualifications:

Education Minimum Requirement: 

• Bachelor’s degree in Life Sciences and minimum 4 years related experience, OR Master’s degree in Life Sciences and minimum 3 years related experience

*eg, knowledge of clinical trial management and trial execution; experience in health-related, life science or analytical related field with experience managing cross-functional teams and projects

Required Experience and Skills:

• Knowledge of GCP, ICH guidelines, and regulatory requirements

• Knowledge of drug development and clinical trial processes, including related standards and documents

• Ability to partner effectively with internal and external teams to achieve results

• Strong team collaboration, leadership, and communication (written and verbal) skills

• Ability to identify issues and develop mitigation plans

• Ability to manage/track milestones and deliverables for multiple projects at a time

Preferred Experience and Skills:

• Global Phase 1 clinical trials experience

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies establi