X4 Pharmaceuticals
Base Pay Range
$140,000.00/yr - $155,000.00/yr
Reporting to Vice President, Clinical Operations
Accountabilities And Responsibilities
Accountable for select aspects of clinical trial operations, including CRO and third‑party vendor management, site management, and timeline and budget
Facilitate the request for proposal(s) process for selecting CROs or any new vendor and participate in the evaluation of potential services.
Create or assist in the development and/or review of study documents and systems (protocol, ICF, monitoring plan, study manuals, eCRFs, IVRS, etc.)
Own and/or support study timelines and study status and proactively communicate updates and risks to timelines, quality, and/or budget‑related items.
Manage and monitor progress of study deliverables (ex. site activations, enrollment, etc.)
Accountable for the creation, management, and negotiation of clinical site budgets and/or sponsor oversight of third parties responsible for these activities
Accountable for study‑specific budget activities including review and approval of vendor invoices, identification of out‑of‑scope activities and impact to overall budget, and support in monthly and annual forecasting.
Accountable for the management and/or support of monitoring (trip report review, creation and compliance to plan, etc.)
Assist in identifying clinical trial sites and contribute to site feasibility and site selection decisions.
Communicate study status both internally and externally in terms of study risks and mitigation plans and develop proactive contingency plans for study‑level risks.
Contribute or organize Investigator Meetings and CRA trainings.
Provide expertise to study drug and clinical supplies forecasting and help oversee proper drug accountability and reconciliation.
Oversee maintenance of study‑related data and files in the Clinical Trial Management System (CTMS), if applicable, and electronic Trial Master File (eTMF).
Contribute to a culture of inspection readiness and support internal and external audits and inspections.
Ensure compliance with clinical trials requirements as well as any applicable Standard Operating Procedures (SOPs).
Provide input and coordinate the development of best practices and functional SOPs.
Requirements
Bachelor’s degree required.
5‑7 years of relevant Clinical Operations experience in the biotech/pharmaceutical industry, minimum of 2+ years independent trial management experience preferred.
Excellent organizational and time‑management skills.
Demonstrated communication skills skillfully and clearly articulating timelines, deliverables, and study questions/issues in cross‑functional and multi‑level teams.
Prior experience successfully managing and developing study documents.
Known for proactive problem solving and success meeting deadlines and demonstrating effective use of time to meet priorities.
Able to manage multiple projects simultaneously, in a fast‑changing environment.
Knowledge of ICH/GCP and regulatory guidelines.
Proven relationship and vendor management skills, with success moving through conflict.
Ability to lead study teams and build cross‑functional relationships internally and externally.
Technical proficiency in MS applications such as Word, Excel, EDC, IVRS/IWR, etc.
Highly respected for commitment to integrity, professionalism, and respect for patients.
This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days/week in the office.
About X4 Pharmaceuticals X4 Pharmaceuticals is an Equal Opportunity, and Affidavit Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law.
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Reporting to Vice President, Clinical Operations
Accountabilities And Responsibilities
Accountable for select aspects of clinical trial operations, including CRO and third‑party vendor management, site management, and timeline and budget
Facilitate the request for proposal(s) process for selecting CROs or any new vendor and participate in the evaluation of potential services.
Create or assist in the development and/or review of study documents and systems (protocol, ICF, monitoring plan, study manuals, eCRFs, IVRS, etc.)
Own and/or support study timelines and study status and proactively communicate updates and risks to timelines, quality, and/or budget‑related items.
Manage and monitor progress of study deliverables (ex. site activations, enrollment, etc.)
Accountable for the creation, management, and negotiation of clinical site budgets and/or sponsor oversight of third parties responsible for these activities
Accountable for study‑specific budget activities including review and approval of vendor invoices, identification of out‑of‑scope activities and impact to overall budget, and support in monthly and annual forecasting.
Accountable for the management and/or support of monitoring (trip report review, creation and compliance to plan, etc.)
Assist in identifying clinical trial sites and contribute to site feasibility and site selection decisions.
Communicate study status both internally and externally in terms of study risks and mitigation plans and develop proactive contingency plans for study‑level risks.
Contribute or organize Investigator Meetings and CRA trainings.
Provide expertise to study drug and clinical supplies forecasting and help oversee proper drug accountability and reconciliation.
Oversee maintenance of study‑related data and files in the Clinical Trial Management System (CTMS), if applicable, and electronic Trial Master File (eTMF).
Contribute to a culture of inspection readiness and support internal and external audits and inspections.
Ensure compliance with clinical trials requirements as well as any applicable Standard Operating Procedures (SOPs).
Provide input and coordinate the development of best practices and functional SOPs.
Requirements
Bachelor’s degree required.
5‑7 years of relevant Clinical Operations experience in the biotech/pharmaceutical industry, minimum of 2+ years independent trial management experience preferred.
Excellent organizational and time‑management skills.
Demonstrated communication skills skillfully and clearly articulating timelines, deliverables, and study questions/issues in cross‑functional and multi‑level teams.
Prior experience successfully managing and developing study documents.
Known for proactive problem solving and success meeting deadlines and demonstrating effective use of time to meet priorities.
Able to manage multiple projects simultaneously, in a fast‑changing environment.
Knowledge of ICH/GCP and regulatory guidelines.
Proven relationship and vendor management skills, with success moving through conflict.
Ability to lead study teams and build cross‑functional relationships internally and externally.
Technical proficiency in MS applications such as Word, Excel, EDC, IVRS/IWR, etc.
Highly respected for commitment to integrity, professionalism, and respect for patients.
This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days/week in the office.
About X4 Pharmaceuticals X4 Pharmaceuticals is an Equal Opportunity, and Affidavit Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law.
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