Clinical Study Manager
Socket
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Study Project Manager II drives the connection between the asset and operational delivery and execution of one or more clinical research studies. Leading the delivery of clinical operational strategies to ensure studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. The Study Project Manager II achieves these objectives by bringing scientific acumen, strategic asset level thinking, innovation, expertise in clinical study operations management and stakeholder management to address risks and challenges. Responsibilities Defines and drives the study level operational strategies and deliverables – linking these to asset level goals Brings strategic, asset level thinking and innovative problem solving to study planning and execution Responsible for executing clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures). Effectively present and contribute to discussions on study operations at asset level strategic meetings Leads clinical operations planning through to execution via cross functional matrix environment and influences cross functional stakeholders to drive milestone achievement Demonstrates the skills, experience and critical thinking to lead cross functional teams with minimal supervision. Expertise in end-to-end clinical study operations management (all phases, set up to close out) Coaches and mentors team members, delegates and empowers to the right level, actively contributes to Development Operations community Demonstrates leadership with high level cross functional stakeholder management and influencing skills Lead operational efficiencies and foster a culture of innovation On a given study responsible for (but not limited to) The development of the clinical study design and associated systems, tools and documents Study budget creation and oversight Vendor selection, scope development, management and oversight of external vendors Proactively identifying risks and address and/or escalation study related issues and opportunities for efficiency Empowered decision maker on operational aspects of study execution. Qualifications Bachelor’s Degree or equivalent degree is required, 8 years of demonstrated pharma-related and/or clinical research related experience or equivalent required. Preferred Oncology Clinical Trial Experience Preferred exposure in study initiation through study completion in Phase 1-4 and/or Clinical Trial Experience Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: #J-18808-Ljbffr
$95k - $105k
...on a range of projects involving the set-up and management of de novo, global real-world evidence (RWE) studies, including ethics applications and site support Salary... ...About the Role We are seeking an experienced clinical research professional to join the RWE team at Costello...SuggestedPermanent employmentFull timeContract workTemporary workWork at officeLocal areaWork from homeFlexible hours- ...services company powering the acceleration of clinical research to transform patient outcomes.... ...world-wide. The Research Finance Manager is a senior leader at the intersection of... ...leadership, and the operational rigor to keep study startup moving efficiently at scale. Where...SuggestedContract workTemporary workFor contractorsFor subcontractorH1bWork at officeLocal areaWork visa2 days per week
- ...Facebook, Instagram, X and YouTube. Job Description Purpose: The Study Project Manager I drives the connection between science and operational... ...operational excellence in planning and execution of clinical research studies across all development stages. The Study Project...Suggested
$164k - $199k
...scientific or healthcare discipline, with 8+ years of clinical operations experience, including 4+ years as a clinical trial manager, leading cross-functional teams and... ...management activities and lead the cross-functional study teamContribute to the development and...SuggestedContract workLocal area- ...Clinical Data Management Leader Provide leadership, strategic planning, direction and implementation of clinical systems for data collection... ...budgeting, resource planning, vendor oversight, EDC build and study timelines, etc. Perform or provide oversight to staff...Suggested
- ...Clinical Data Manager A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well... ...capabilities to achieve quality, timely, cost-effective study deliverables. Coordinating program work of Data Manager and...Work at office
- ...liaison between Company and CRO for Data Management. Provide support and oversight for... ...Management team. Collaborate with the team on study design, protocol development, CRF design... ...planning, and CSRs. Review clinical study protocols and provide comments if...
- ...Senior Clinical Data Manager Odyssey Therapeutics is propelling drug development beyond what is now possible to deliver medicines that address... ...Manager to own clinical data management deliverables from study start-up through close-out. Reporting to the Director of...
- ...General Hospital is seeking applications for a full-time Project Manager to work on projects led by Dr. Matthew Nock aimed at better... ...division. Responsible for the management of multiple clinical research studies and the direct hiring and supervision of Clinical Research...Full timeTemporary workRemote workShift work
$225k - $315k
Cambridge, MADevelopment - Clinical Pharmacology /Full-Time /On-siteScholar Rock is a late-stage global biopharmaceutical company focused... ...Development (MIDD).Contribute to clinical protocol design, study execution, data analysis, and writing clinical study reportsCollaborate...Full time- Job DescriptionGeneral Summary:The Medical Writing Science Senior Manager is responsible for independently authoring complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development. This role may represent Medical...Full timeSummer workWork at officeRemote workFlexible hours2 days per week3 days per week
$171k - $273k
Job TitleDirector, Clinical Affairs of Coronary/VascularJob DescriptionDirector, Clinical... ...market, registry, and real-world evidence studies. Direct study design, protocol... ...claims, publication strategies, lifecycle management, and global evidence dissemination. Ensure...Full timeWork at officeImmediate startWork visaRelocation package3 days per week$177k - $278.08k
...Position Objectives: Drives, or contributes to, strategy for clinical studies within the overall global clinical development for assigned... ...significance to individual patients.May present study conclusions to Management and determine how individual study results impact the...Minimum wageTemporary workLocal areaNight shift$237.2k - $372.79k
...to shine? Join us as a Medical Director, Clinical Science, GI2 TAU in our Cambridge, MA... ...Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the... ...data from ongoing internal and external studies, assessing the medical and scientific...Minimum wageTemporary workWork at officeLocal areaRemote work$183.8k - $330.3k
...Therapeutic programs, specifically supporting the Clinical Development Lead in the direction,... ...and evaluation of Phase 1-3 clinical studies. The principal responsibility for this... ...Clinical Safety & Pharmacovigilance, support managing study sites to ensure that study...Permanent employmentFull timeWork at officeWork from home$206.25k - $343.75k
...serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market... ...with field teams, global teams, alliance management and the relevant U.S. cross-functional partners... ...execution of US Phase IIIB-IV clinical study programs, including preparation of study...Full timeLocal area$120.2k - $180.4k
...DescriptionGeneral Summary:The Medical Writing Science Manager is responsible for preparing moderately complex clinical and regulatory documents and represents Medical... ...as a cross-functional team member at clinical study level activities. This role contributes...Full timeSummer workRemote workFlexible hours2 days per week- Job DescriptionGeneral Summary:The Clinical Pharmacology Director leads strategic, scientific... ...plans; assists in departmental management through program reviews and collaborative... ...PharmacologyExperience conducting and supervising clinical studies such as drug-drug interaction, special...Full timeSummer workRemote workFlexible hours2 days per week
$237.2k - $372.79k
...US/EU/Japan/other regions and countries) clinical development for assigned Takeda pipeline... ...data from ongoing internal and external studies, assessing the medical and scientific... ...Leadership, Task Force Participation, Upper Management Accountability: interacts directly with...Minimum wageTemporary workLocal areaWorldwideFlexible hours- Overview:The Director, Clinical Science will be a member of the global clinical development... ...statistician, medical safety director, safety manager and clinical pharmacologist) to support... ...development strategy assisting with study design, protocol concept sheet, protocol...Full timeTemporary workLocal areaFlexible hours
- ...DescriptionGeneral Summary:The Senior Director, Clinical Pharmacology will serve as a Disease Area... ..., Clinical Pharmacology will also manage the scientific functions and coordinate the... ...execute Clinical Pharmacology plans and studies for Disease Area programsDirects Clinical...Full timeSummer workRemote workFlexible hours2 days per week
$237.2k - $372.79k
...to shine? Join us as a Medical Director, Clinical Science, GI2 TAU in our Cambridge, MA... ...and other documents needed for CDP and study execution and regulatory submissions. Recommends... ...studies.Presents study conclusions to Management and determines how individual study...Minimum wageTemporary workWork at officeLocal areaRemote workNight shift$185k - $240k
OverviewThe Director Clinical Scientist is an important and visible member of the Clinical... ...final recommendations to senior management.ResponsibilitiesSupports the clinical lead... ...leads clinical execution of one or more studies. May be accountable for program level clinical...$206.25k - $297.92k
...serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market... ...Medical Directors, Medical Science Liaison Managers, and Medical Science Liaisons) by cultivating... ...execution of US Phase IIIB-IV clinical study programs.Support the review and approval...Full time$220k - $245k
...understanding of their bodies and daily lives.As the Director, Clinical Science, you will lead the clinical science function responsible... ...deep expertise in SaMD clinical development, including study design, endpoint development, clinical validation, regulatory strategy...Full timeWork at officeRemote workRelocation$139.1k - $231.9k
Responsible for the scientific and clinical oversight of clinical trials in support of the... ...and resourcing needs.The Senior Manager partners with other clinical and medical... ...program. This role is central to ensuring studies are conducted with the highest scientific...Permanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week- AstraZeneca is advancing a tailored approach to Obesity and Weight Management, uniting science, medical and commercial excellence to... ..., enabling outstanding product launches, practice-defining clinical studies, generation of real-world evidence, transformation of health...Hourly payFull timeTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week
- ...immunology pipeline and lead innovative clinical stage programs. In this position, you will... ...clinical development plans and clinical study design, as well writing protocols, medical... ...and program goals Demonstrated experience managing complex projects and working...Full timeWork at officeFlexible hours3 days per week
$276k - $414k
...-franchise products from first in-human clinical trials, into and throughout commercialization... ..., planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO... ...planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week$286.9k
...an Executive Medical Director, Oncology Clinical Sciences in our Cambridge, MA office. At... ...review of synopses, other relevant clinical study documents, and critical study results.... ...development activity, including the management of a team of individuals responsible for...Minimum wageTemporary workWork at officeLocal areaNight shift
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