Clinical Program Lead
Company: Disability Solutions
Location: Boston
Posted on: April 18, 2024
Job Description:
About the Job
The Clinical Program Lead, Clinical Operations and Data Management
provides comprehensive operational support for FMI's participation
in clinical trials sponsored by biopharma partners, academic
partners, and FMI-led trials. This position is responsible for
developing, implementing and monitoring the execution plans for the
clinical studies they support from initial study intake through
final project deliverables. The position maintains proactive, clear
and customer-centric communication, day-to-day project management,
and operational excellence with a solutions-oriented mindset and a
keen focus on problem solving. The Clinical Program Lead works
collaboratively with internal and external stakeholders across
functions to manage samples, timelines, resource plans and critical
path activities, directly impacting the successful implementation
and on-going execution of clinical studies.
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Key Responsibilities
Study Planning and Start-Up
- Facilitate study intake process with partner/collaborator,
evaluate feasibility of study with internal stakeholders and obtain
FMI approval to support clinical trial (via CSP, SRC, or PRORECO
meeting) with finalized SOW.
- Communicate decisions to external partners and
collaborators.
- Support internal FMI study start-up activities including
contracting, finalization of study materials including manuals,
study specific requisition forms/kits, project specific plans and
sample processing guidelines.
- Collaborate with partner to establish working approach,
including optimization of communication and sharing of
tools.
- Deliver study start-up training with partner and external
clinical trial sites as required.
- Deliver study start-up training with internal stakeholders.
Trial Operations
- Manage the implementation, on-time execution and conduct of FMI
support of clinical studies, including the management of
milestones, timelines and deliverables, development and management
of budget/finances, sample forecasting and invoicing, and
management of resources.
- Work and collaborate closely with laboratory teams and Process
Specialists to ensure sample tracking and chain of custody is
maintained through accessioning through data/report
delivery.
- Partner with the Data Management and Data Reporting Team to
ensure timely delivery of a quality data product in line with
partner expectations and contractual deliverables.
- Identify and mitigate against study risks, escalating as
necessary.
- Engage in problem solving as needed related to sample receipt,
accessioning, tracking, genomic analysis, report generation and
dissemination.
- Effectively track and communicate program/study progress to
partners, including through creation and updating of detailed
dashboards and trackers.
- Provide study updates and escalate as needed to FMI leadership
including Clinical Operations Data Management, Alliance Management
and Clinical Development.
- Ensure timely documentation, and communication of decisions,
and updates on timelines and deliverables.
- Support Laboratory Operations and Process Specialists with
sample return and destruction process for partner and collaborator
samples.
- Support partner/collaborator and internal process
audits.
- Contribute to study close-out reports and close studies within
FMI systems.
Communication/Other
- Maintain documentation on key study contacts (internal and
external).
- Build and maintain relationships with internal and external
stakeholders and provide study updates as needed to Clinical
Operations and biopharma leadership.
- Lead partner-facing study meetings.
- Maintain an awareness of competitive landscape, changing
regulations and guidance, assess the impact on clinical projects,
and make modifications as necessary.
- Creatively approach challenges and problem resolution to
optimize the conduct of clinical trials.
Process Oversight and Study Compliance
- Support Clinical Operations initiatives to improve study
management and data management processes.
- Serve as an FMI resource regarding clinical trial
regulations.
- Track, resolve and communicate NCRs/process deviations with
direct impact on study operations to partners.
- Initiate CAPAs in conjunction with Process and Training Leads
and QA to correct and prevent issues from reoccurring.
- Other duties as assigned.
--
Qualifications:
Basic Qualifications:
- Bachelor's Degree in a scientific field or 4+ years of
experience in clinical trial or data management roles in lieu of a
Degree, AND
- 2+ years of clinical trial or data management experience in a
professional life science environment
Preferred Qualifications:
- Masters or Advanced Degree in a business or scientific
discipline
- 3+ years of clinical operations experience in the
biopharmaceutical or diagnostic industry or an academic medical
center
- 1+ years of professional or academic experience:
- in clinical oncology trials
- in a Clinical Research Organization (CRO) or lab vendor
environment
- handling complex clinical data sets including genomic data
- Demonstrated history of successfully managing multiple
concurrent initiatives and maintaining one's own workflow in a
fast-paced, dynamic environment
- Demonstrated evidence of success working in a cross-functional
environment; able to build strong relationships
- Strong organizational skills
- Excellent attention to detail
- Ability to work well under pressure while maintaining a
professional demeanor
- Understanding of ICH GCP regulations and guidelines as they
apply to the conduct of clinical trials globally
- Understanding of HIPAA and importance of patient safety and
data privacy regulations and guidelines
- Commitment to reflect FMI's values: Patients, Passion,
Innovation, and Collaboration
#LI-Hybrid
Keywords: Disability Solutions, Brookline , Clinical Program Lead, Healthcare , Boston, Massachusetts
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