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Actalent Senior Clinical Operations Lead in Cambridge, Massachusetts

Senior Clinical Operations Lead

Remote but preference is someone that is based in New England

RESPONSIBILITIES:

  • Serve as primary operational contact and lead the cross-functional Clinical Study Team(s) in the execution of early phase oncology clinical trials in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions

  • Ensure successful planning, execution, tracking, and delivery of quality clinical trials/deliverables within specified timeline and budget

  • Lead or participate in the selection, start-up, and management/oversight of clinical service providers/vendors (CRO, RTSM/IXRS, labs, etc.)

  • Develop/maintain effective investigator and internal and external collaborator relationships

  • Lead/assist in development of study oversight plans, quality plans, clinical components of regulatory submissions, risk management and corrective action plans, and study documents such as protocol, Investigator Brochure, informed consent forms, study execution plans, CRFs, Clinical Study Reports, etc.

  • Develop innovative country, site activation, and subject recruitment/retention strategies and related initiatives

  • Coordinate and/or oversee the study training for study teams, investigational sites, and vendors in collaboration with CRO

  • Monitor/oversee data quality and CRA, site, CRO/vendor performance/metrics and effectiveness of mitigative/corrective measures

  • Proactively manage issues and information sharing with key internal and external stakeholders with use of standardized reports and other mechanisms

  • Oversee, with support from the Clinical Trial Associate, the creation, maintenance, and transfer of the electronic Trial Master File (eTMF)

  • Participate and respond to Quality Assurance and/or regulatory authority inspections and audits of sites and vendors

  • Oversee scopes of work, invoice reconciliation, and change orders and participate in reconciliation of monthly actual and forecast budgets

  • Evaluate and support the development and application of standardized operational processes and continuous process improvement initiatives, recommending/taking the lead for more efficient and/or effective approaches to clinical trials

  • Provide study-specific mentoring and line management for junior team members, as appropriate, as the needs of Clinical Operations grow

EDUCATION AND EXPERIENCE:

  • Bachelor’s degree, or equivalent, in a biomedical, life science or related field of study

  • Minimum 10 years of progressively increasing clinical operations experience within pharma, biotech and/or CRO, with at least 2 years of that time in small biotech

  • Extensive experience and expertise in managing complex clinical studies; early phase oncology experience required

  • Knowledge of and ability to apply current FDA and global regulations and compliance guidelines to clinical trials using “best” industry practices and exercising highest ethical standards

  • Proactive and independent management and oversight of CROs, vendors, and consultants

  • Demonstrated skill in leading and collaborating with cross-functional teams and an ability to influence and provide direction and guidance to colleagues and partners

  • Critical, strategic thinker who uses sound judgment with respect to operational strategies and confidential information

  • Complex problem-solving skills and a broad perspective to deal effectively with ambiguity

  • Independent, able to adapt in a changing and fast-paced environment, not afraid to make decisions

  • Proficient in study monitoring activities

  • Strong understanding of cost drivers with the ability to proactively develop and manage/oversee study and clinical development program budgets and timelines

  • Strong verbal, written, presentation and computer skills, including knowledge of Microsoft Excel, Word, PowerPoint, Outlook and Project/equivalent

  • Flexibility to travel as needed, when the timing is appropriate (10-15%)

    About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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