Associate Director Clinical Operations
Advantage Technical, Waltham, MA, United States
Associate Director, Clinical Programs
Location:
Waltham, MA 02451,
Hybrid preferred (open to remote candidates)
Pay Rate:
Up to $140 an hour or about $288,000 a year
Job Type:
Long Term Contract
Please make an application promptly if you are a good match for this role due to high levels of interest.
Position Overview
The Associate Director, Clinical Programs is responsible for the oversight, coordination, and execution of clinical studies supporting broader clinical programs. This role combines hands-on trial management with program-level operational leadership to ensure studies are executed efficiently and aligned with program objectives.
Key Responsibilities
Serve as a core clinical project team member, working closely with the Clinical Program Manager (CPM) to lead the execution, oversight, and delivery of assigned clinical studies, timelines, and key milestones.
Operate at a program-manager level for day-to-day trial operations while contributing to broader program strategy and operational planning.
Provide hands-on leadership to initiate and advance studies, particularly during early phases or transitional periods where strategy is still evolving.
Develop, manage, and track study budgets, including financial reporting, invoice and PO reconciliation, accrual tracking, and forecasting in collaboration with Clinical Outsourcing, Finance, and Project Management.
Monitor study progress, timelines, and performance metrics, ensuring accurate and timely reporting.
Lead and contribute to the development of key clinical study documents, including informed consent forms (ICFs), monitoring plans, recruitment strategies, and other study-related materials.
Partner with Clinical Program Management in the selection of CROs and vendors, including managing the RFP process, and leading contract and budget negotiations.
Serve as a key decision-maker in CRO selection alongside the CPM and Clinical Program Management team.
Oversee and manage relationships with CROs, vendors, investigators, monitors, and other external stakeholders.
Lead cross-functional clinical team meetings and serve as the primary point of contact for study-level updates.
Direct and coordinate study start-up activities, including feasibility assessments, investigational product and material preparation, trial master file (TMF) setup, CRF development, regulatory documentation, and site contracting.
Support data management activities, including database development, user acceptance testing (UAT), edit check input, and data cleaning efforts across sites and vendors.
Collaborate with the CPM to ensure timely receipt and integration of ancillary data (e.g., safety labs, analytical data, IVRS randomization data) for database lock.
Contribute to SOP development, process improvements, and training/mentorship of junior Clinical Trial Managers and Clinical Trial Assistants (CTAs).
Independently manage complex or multiple clinical studies, providing senior-level leadership to drive execution and results.
Qualifications
Education:
Bachelor’s degree in a scientific or healthcare-related field required; Master’s degree preferred.
Experience:
10+ years of clinical research experience within pharmaceutical, biotechnology, or CRO environments; monitoring experience is a plus.
Strong knowledge of
GCP/ICH guidelines
and clinical trial regulations.
Demonstrated leadership, organizational, and multitasking abilities.
Excellent problem-solving skills and attention to detail.
Strong interpersonal and communication skills, with the ability to work effectively in cross-functional teams.
General Notes
This is a senior-level, hands-on leadership role ideal for candidates who can operate both strategically and tactically within clinical operations. xywuqvp
Candidates must be comfortable driving studies forward in dynamic and evolving environments.
Location:
Waltham, MA 02451,
Hybrid preferred (open to remote candidates)
Pay Rate:
Up to $140 an hour or about $288,000 a year
Job Type:
Long Term Contract
Please make an application promptly if you are a good match for this role due to high levels of interest.
Position Overview
The Associate Director, Clinical Programs is responsible for the oversight, coordination, and execution of clinical studies supporting broader clinical programs. This role combines hands-on trial management with program-level operational leadership to ensure studies are executed efficiently and aligned with program objectives.
Key Responsibilities
Serve as a core clinical project team member, working closely with the Clinical Program Manager (CPM) to lead the execution, oversight, and delivery of assigned clinical studies, timelines, and key milestones.
Operate at a program-manager level for day-to-day trial operations while contributing to broader program strategy and operational planning.
Provide hands-on leadership to initiate and advance studies, particularly during early phases or transitional periods where strategy is still evolving.
Develop, manage, and track study budgets, including financial reporting, invoice and PO reconciliation, accrual tracking, and forecasting in collaboration with Clinical Outsourcing, Finance, and Project Management.
Monitor study progress, timelines, and performance metrics, ensuring accurate and timely reporting.
Lead and contribute to the development of key clinical study documents, including informed consent forms (ICFs), monitoring plans, recruitment strategies, and other study-related materials.
Partner with Clinical Program Management in the selection of CROs and vendors, including managing the RFP process, and leading contract and budget negotiations.
Serve as a key decision-maker in CRO selection alongside the CPM and Clinical Program Management team.
Oversee and manage relationships with CROs, vendors, investigators, monitors, and other external stakeholders.
Lead cross-functional clinical team meetings and serve as the primary point of contact for study-level updates.
Direct and coordinate study start-up activities, including feasibility assessments, investigational product and material preparation, trial master file (TMF) setup, CRF development, regulatory documentation, and site contracting.
Support data management activities, including database development, user acceptance testing (UAT), edit check input, and data cleaning efforts across sites and vendors.
Collaborate with the CPM to ensure timely receipt and integration of ancillary data (e.g., safety labs, analytical data, IVRS randomization data) for database lock.
Contribute to SOP development, process improvements, and training/mentorship of junior Clinical Trial Managers and Clinical Trial Assistants (CTAs).
Independently manage complex or multiple clinical studies, providing senior-level leadership to drive execution and results.
Qualifications
Education:
Bachelor’s degree in a scientific or healthcare-related field required; Master’s degree preferred.
Experience:
10+ years of clinical research experience within pharmaceutical, biotechnology, or CRO environments; monitoring experience is a plus.
Strong knowledge of
GCP/ICH guidelines
and clinical trial regulations.
Demonstrated leadership, organizational, and multitasking abilities.
Excellent problem-solving skills and attention to detail.
Strong interpersonal and communication skills, with the ability to work effectively in cross-functional teams.
General Notes
This is a senior-level, hands-on leadership role ideal for candidates who can operate both strategically and tactically within clinical operations. xywuqvp
Candidates must be comfortable driving studies forward in dynamic and evolving environments.