Senior Clinical Study Manager Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation ...
New
Senior Clinical Study Manager Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation ...
New
Senior Clinical Study Manager Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation ...
New
Management of the study budget, including Task Orders, Change Orders, invoice approval and financial reconciliation process. The assigned clinical study/studies may be high complexity or high risk, e ...
Management of the study budget, including Task Orders, Change Orders, invoice approval and financial reconciliation process. The assigned clinical study/studies may be high complexity or high risk, e ...
Cambridge, MA · On-site
Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. 1. Manage clinical study/studies according to global regulatory requirements (including but not limited to US CFR ...
Cambridge, MA · On-site
Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. 1. Manage clinical study/studies according to global regulatory requirements (including but not limited to US CFR ...
Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. 1. Manage clinical study/studies according to global regulatory requirements (including but not limited to US CFR ...
Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. 1. Manage clinical study/studies according to global regulatory requirements (including but not limited to US CFR ...
Cambridge, MA · On-site
Management of the study budget, including Task Orders, Change Orders, invoice approval and financial reconciliation process. Accountabilities: 1. Manage clinical study/studies according to global ...
Cambridge, MA · On-site
Management of the study budget, including Task Orders, Change Orders, invoice approval and financial reconciliation process. Accountabilities: 1. Manage clinical study/studies according to global ...
Job Title: Lead Clinical Study Manager (Lead CSM) BU/Organization: Global Development Organization (GDO) Department/ Function: Global Clinical Development Operations (GCDO) / Study Management ...
Job Title: Lead Clinical Study Manager (Lead CSM) BU/Organization: Global Development Organization (GDO) Department/ Function: Global Clinical Development Operations (GCDO) / Study Management ...
Cambridge, MA · On-site
Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. 1. Manage clinical study/studies according to global regulatory requirements (including but not limited to US CFR ...
Cambridge, MA · On-site
Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. 1. Manage clinical study/studies according to global regulatory requirements (including but not limited to US CFR ...
Coordinate activities with the Preclinical Study Manager, Project Toxicologist, DMPK, Bioanalytical, CMC and other functional areas to ensure efficient execution of nonclinical studies.
Coordinate activities with the Preclinical Study Manager, Project Toxicologist, DMPK, Bioanalytical, CMC and other functional areas to ensure efficient execution of nonclinical studies.
Coordinate activities with the Preclinical Study Manager, Project Toxicologist, DMPK, Bioanalytical, CMC and other functional areas to ensure efficient execution of nonclinical studies.
Coordinate activities with the Preclinical Study Manager, Project Toxicologist, DMPK, Bioanalytical, CMC and other functional areas to ensure efficient execution of nonclinical studies.
Boston, MA · On-site +1
Join us as a Lead Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market ...
Boston, MA · On-site +1
Join us as a Lead Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market ...
The Clinical Study Design Manager is responsible for working with our clients and internal staff to define the eSource platform specification design for the study, including all data capture ...
The Clinical Study Design Manager is responsible for working with our clients and internal staff to define the eSource platform specification design for the study, including all data capture ...
Boston, MA · On-site
The Clinical Study Design Manager is responsible for working with our clients and internal staff to define the eSource platform specification design for the study, including all data capture ...
Boston, MA · On-site
The Clinical Study Design Manager is responsible for working with our clients and internal staff to define the eSource platform specification design for the study, including all data capture ...
Boston, MA · On-site
$138 - $207/hr
The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to help ensure they are conducted in compliance with Good Clinical Practice (GCP ...
Boston, MA · On-site
$138 - $207/hr
The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to help ensure they are conducted in compliance with Good Clinical Practice (GCP ...
Boston, MA · On-site
$120 - $180/hr
The Clinical Study Design Manager is responsible for working with our clients and internal staff to define the eSource platform specification design for the study, including all data capture ...
Boston, MA · On-site
$120 - $180/hr
The Clinical Study Design Manager is responsible for working with our clients and internal staff to define the eSource platform specification design for the study, including all data capture ...
Waltham, MA · On-site
Ensure studies are conducted in accordance with ICH-GCP, FDA regulations, company SOPs, and ... Ability to take direction and manage multiple tasks. About TScan: TScan Therapeutics is a fully ...
Waltham, MA · On-site
Ensure studies are conducted in accordance with ICH-GCP, FDA regulations, company SOPs, and ... Ability to take direction and manage multiple tasks. About TScan: TScan Therapeutics is a fully ...
Drive study startup activities, including feasibility, site selection, and timelines. * Manage activities of Phase 1 and 2 clinical trial investigators with a focus on the US to ensure compliance ...
Drive study startup activities, including feasibility, site selection, and timelines. * Manage activities of Phase 1 and 2 clinical trial investigators with a focus on the US to ensure compliance ...
Ensure studies are conducted in accordance with ICH-GCP, FDA regulations, company SOPs, and ... Ability to take direction and manage multiple tasks. About TScan: TScan Therapeutics is a fully ...
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Ensure studies are conducted in accordance with ICH-GCP, FDA regulations, company SOPs, and ... Ability to take direction and manage multiple tasks. About TScan: TScan Therapeutics is a fully ...
Ensure studies are conducted in accordance with ICH-GCP, FDA regulations, company SOPs, and ... Ability to take direction and manage multiple tasks. About TScan: TScan Therapeutics is a fully ...
Ensure studies are conducted in accordance with ICH-GCP, FDA regulations, company SOPs, and ... Ability to take direction and manage multiple tasks. About TScan: TScan Therapeutics is a fully ...
Boston, MA · On-site
$93 - $233/hr
Collaborates with central study teams and local stakeholders as applicable for final selection of ... Delivers advanced vendor management at the country level to support the study and may submit ...
Boston, MA · On-site
$93 - $233/hr
Collaborates with central study teams and local stakeholders as applicable for final selection of ... Delivers advanced vendor management at the country level to support the study and may submit ...
Cambridge, MA · On-site +1
Drive study startup activities, including feasibility, site selection, and timelines. * Manage activities of Phase 1 and 2 clinical trial investigators with a focus on the US to ensure compliance ...
Cambridge, MA · On-site +1
Drive study startup activities, including feasibility, site selection, and timelines. * Manage activities of Phase 1 and 2 clinical trial investigators with a focus on the US to ensure compliance ...
$26.6K - $35.7K
9% of jobs
$35.7K - $44.7K
15% of jobs
$45.4K is the 25th percentile. Wages below this are outliers.
$44.7K - $53.8K
17% of jobs
The median wage is $56.9K / yr.
$53.8K - $62.8K
27% of jobs
$68.4K is the 75th percentile. Wages above this are outliers.
$62.8K - $71.9K
12% of jobs
$71.9K - $80.9K
8% of jobs
$80.9K - $90K
4% of jobs
$90K - $99K
3% of jobs
$99K - $108.1K
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$108.1K - $117.1K
2% of jobs
$117.1K - $126.2K
1% of jobs
$26.6K
$64.7K
$126.2K

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Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Manage clinical study/studies according to global regulatory requirements and Takeda SOPs, and supporting clinical strategy defined in Clinical Study Plan. Lead cross functional Study Execution Team, Strategic Partners and other vendors to ensure study goals are met, on time and within budget. Ensure appropriate regional input for global or multinational studies prior to decision making. Responsible for communication of study information to Clinical Operations regions. Contributes to protocol synopsis development and to Clinical Study Plan development, including Clinical Operations feasibility assessments. Leads the cross functional protocol development process, including responsibility for any protocol amendments or administrative changes. Management of Strategic Partners, including setting expectations, training, CRO Oversight process, Task Orders, Change Orders, invoice approval and financial reconciliation process for assigned study. Leads the evaluation and selection of required vendors, including contract and budget negotiation, invoice approval and financial reconciliation process. Provides Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock, writing the Clinical Study Report. Escalates medical issues to appropriate medical personnel. Provides regular budget updates to Clinical Program Manager, or Finance when required. In collaboration with Study Execution Team, identify risks to study and develop risk mitigation plans, including communication and collaboration with Clinical Program Manager and Associate Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning. Able to assist Clinical Program Manager and may represent Clinical Program Manager, when necessary. Participates in Clinical Operations or cross functional initiatives.
Education: Bachelors Degree, RN, or international equivalent required, Life Sciences preferred. Skills: Good understanding of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required. Solid teamwork, organizational, interpersonal, and problem solving skills; Fluent business English (oral and written) and basic medical writing skills Experience: Minimum of 5 years of experience in clinical research in the pharmaceutical industry or clinical research organization. CRA experience preferred. Protocol writing/study design experience required. Experience in more than one therapeutic area is required.