Senior Clinical Trial Manager
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden.
For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and have helped physicians enhance patient care with our broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.
Lantheus is in search of an innovative, transformative, high-energy, experienced Principal Supplier Quality Analyst for our Quality Systems team.
At Lantheus.
our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success.
Every employee is crucial to our success, we respect one another and act as one knowing that someone's health is in our hands.
We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skills sets to be a part of a productive and inclusive team.
Senior Clinical Trial Manager (Sr CTM), Clinical Operations leads the planning, execution and conduct of complex clinical studies while adhering to budget, scope, and timelines.
The Sr.
CTM is responsible for managing all aspects of multiple clinical trials with emphasis on CRO and vendor management to drive a high functioning and results-driven team including timeline adherence, patient safety, adherence to contracted deliverables, the protocol(s), appropriate regulations, and data integrity.
The Sr.
CTM/CTM is expected to provide leadership within the department and to make recommendations with regards to the strategic aspects of Clinical Operations deliverables, timelines, budgets, and resourcing.
Key Responsibilities / Essential Functions Serve as primary Operations contact for internal and external study team members/vendors on assigned studies and as the escalation point for vendors, investigators, and sites Contribute to the RFP process with a focus on operations-related vendors and study activities in collaboration with the Procurement organization Participate in the selection of CROs, consultants, and other vendors Contribute to management decisions on study team resourcing requirements and strategy Collaborate with identified stakeholders to establish and manage the functional study timelines and budgets; escalate significant risks or changes Manage vendor oversight and coordinate cross-functional activities to successfully achieve study milestones and quality deliverables Lead, contribute, and/or review the development of study-specific plans, study documents, and processes; these may be developed in collaboration with study vendors Ensure studies are conducted in accordance with the protocol, ICH-GCP guidelines, governmental and country regulations, and applicable SOPs Report on the overall status of assigned clinical trials including defined metrics, key performance indicators, timelines, and budgets Assess risks to study performance, timelines, and budgets; preemptively plan risk mitigation strategies Oversee and contribute to development of key study documents including protocols, protocol amendments, case report forms, study plans and manuals, informed consent forms, study documents, clinical study reports, annual reports, key safety reports, and regulatory documents Perform ongoing assessment of operational efficiency and communication and adjust study processes to ensure high team performance Plan and prepare for investigator meetings Oversee forecasting of clinical supplies and non-clinical supplies for a study Contribute to the development, maintenance, and updating of Clinical Operations and Clinical Development SOPs Lead / participate in departmental initiatives.
Mentor junior staff as needed.
Perform other duties as assigned Basic
Qualifications Education:
Bachelor's degree in science or related field
Experience:
Clinical development experience with trial management experience in industry (sponsor or CRO) is required.
Vendor management experience is required.
Oncology and/or radiopharmaceuticals is required Preferred:
Advanced degree.
Monitoring or monitoring oversight experience Other Requirements Possess highly effective interpersonal and analytical skills enabling influencing and negotiation skills Strong problem solving and decision-making skills Strong understanding of clinical trial methodology, drug development process, ICH-GCP guidelines and applicable regulatory requirements Well organized and detail oriented with strong written and verbal communication skills Proficient in MS Office applications Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
41 CFR 60-1.
35(c) Recommended Skills Analytical Attention To Detail Business Efficiency Case Report Forms Clinical Study Reports Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and have helped physicians enhance patient care with our broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.
Lantheus is in search of an innovative, transformative, high-energy, experienced Principal Supplier Quality Analyst for our Quality Systems team.
At Lantheus.
our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success.
Every employee is crucial to our success, we respect one another and act as one knowing that someone's health is in our hands.
We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skills sets to be a part of a productive and inclusive team.
Senior Clinical Trial Manager (Sr CTM), Clinical Operations leads the planning, execution and conduct of complex clinical studies while adhering to budget, scope, and timelines.
The Sr.
CTM is responsible for managing all aspects of multiple clinical trials with emphasis on CRO and vendor management to drive a high functioning and results-driven team including timeline adherence, patient safety, adherence to contracted deliverables, the protocol(s), appropriate regulations, and data integrity.
The Sr.
CTM/CTM is expected to provide leadership within the department and to make recommendations with regards to the strategic aspects of Clinical Operations deliverables, timelines, budgets, and resourcing.
Key Responsibilities / Essential Functions Serve as primary Operations contact for internal and external study team members/vendors on assigned studies and as the escalation point for vendors, investigators, and sites Contribute to the RFP process with a focus on operations-related vendors and study activities in collaboration with the Procurement organization Participate in the selection of CROs, consultants, and other vendors Contribute to management decisions on study team resourcing requirements and strategy Collaborate with identified stakeholders to establish and manage the functional study timelines and budgets; escalate significant risks or changes Manage vendor oversight and coordinate cross-functional activities to successfully achieve study milestones and quality deliverables Lead, contribute, and/or review the development of study-specific plans, study documents, and processes; these may be developed in collaboration with study vendors Ensure studies are conducted in accordance with the protocol, ICH-GCP guidelines, governmental and country regulations, and applicable SOPs Report on the overall status of assigned clinical trials including defined metrics, key performance indicators, timelines, and budgets Assess risks to study performance, timelines, and budgets; preemptively plan risk mitigation strategies Oversee and contribute to development of key study documents including protocols, protocol amendments, case report forms, study plans and manuals, informed consent forms, study documents, clinical study reports, annual reports, key safety reports, and regulatory documents Perform ongoing assessment of operational efficiency and communication and adjust study processes to ensure high team performance Plan and prepare for investigator meetings Oversee forecasting of clinical supplies and non-clinical supplies for a study Contribute to the development, maintenance, and updating of Clinical Operations and Clinical Development SOPs Lead / participate in departmental initiatives.
Mentor junior staff as needed.
Perform other duties as assigned Basic
Qualifications Education:
Bachelor's degree in science or related field
Experience:
Clinical development experience with trial management experience in industry (sponsor or CRO) is required.
Vendor management experience is required.
Oncology and/or radiopharmaceuticals is required Preferred:
Advanced degree.
Monitoring or monitoring oversight experience Other Requirements Possess highly effective interpersonal and analytical skills enabling influencing and negotiation skills Strong problem solving and decision-making skills Strong understanding of clinical trial methodology, drug development process, ICH-GCP guidelines and applicable regulatory requirements Well organized and detail oriented with strong written and verbal communication skills Proficient in MS Office applications Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
41 CFR 60-1.
35(c) Recommended Skills Analytical Attention To Detail Business Efficiency Case Report Forms Clinical Study Reports Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
