Clinical Study Manager
AbbVie
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 Purpose: The Study Project Manager I drives the connection between science and operational delivery and ensures operational excellence in planning and execution of clinical research studies across all development stages. The Study Project Manager I is responsible for and ensures clinical research studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. The Study Project Manager I achieves these objectives by bringing scientific acumen, strategic thinking, innovation, experience in clinical study operations management and stakeholder management to address risks and challenges. The Study Project Manager I serves as leader of one or more cross functional Clinical Study Teams, leading clinical operations from planning through to execution in a cross functional matrix environment. Responsibilities Defines and drives the operational strategies and deliverables for one or more clinical studies Responsible for executing clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures). Proactively manages budget, timelines and study issues; brings scientific acumen, technical expertise and global mindset to drive achievement of study objectives Leader of the cross functional Clinical Study Team Leads clinical operations planning through to execution via cross functional matrix environment and influences cross functional stakeholders to drive milestone achievement Effectively manages vendors and a diverse set of external stakeholders including site staff, Key Opinion Leaders and patient groups Brings a growth mindset, demonstrated by a willingness to continuously learn, grow and adapt, give and receive feedback, see challenges as opportunities Coaches and effectively supports cross functional team members, delegates and empowers to the right level, actively contributes to Development Operations community Contributes towards operational efficiencies and brings innovative ideas to their teams and studies -Demonstrates excellent communication and problem solving skills Puts patients and customers at the center of what we do Navigates ambiguity and thrives even when not having all the information 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 escape study related issues and opportunities for efficiency, being an empowered decision maker on operational aspects of study execution and creating an inclusive and innovative environment where staff and studies/programs will succeed Provide leadership to Study Management Associates – lead, delegate and support activities to deliver on study milestones Qualifications Bachelor’s Degree or equivalent degree is required 6 years of demonstrated pharma-related and/or clinical research related experience or equivalent required. Preferred exposure in study initiation through study completion in Phase 1-4 and/or Medical Device Trial Experience Additional Information 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 thisposting 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 employee remains in the Company's sole and absolute discretion unless anduntil 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
- ...Clinical Study Manager A Few Words About Us 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...SuggestedContract work
$180k - $200k
...intelligence. About the role You'll be the first Clinical hire in the US, leading a team covering... ...Excom priorities into a roadmap of studies, claims, KOLs and communication, in... ...priorities across DS, RAQA, Marketing and Ops Manage and grow a 3-person clinical team, own...SuggestedFull timeRemote workWorldwideFlexible hours- ...that holds the potential to transform human health. The opportunity: Odyssey is seeking a Senior Clinical Data Manager to own clinical data management deliverables from study start‑up through close‑out. Reporting to the Director of Clinical Data Sciences, you’ll...Suggested
- ...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...
- ...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
$63.25k - $102.6k
...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- ...Medical Director, Gastroenterology, Early R&I Clinical Development Join AstraZeneca as the... ...developing clinical plans, designing studies, writing protocols, medical monitoring,... ..., and urgency to meet goals. Experience managing complex projects and stakeholder collaboration...Work at officeWorldwideFlexible hours
- ...Medicines Precision Engineering Clinical Care Cancer Awareness International... ...high level of expertise in global clinical study design, drug development processes, and a... ...collaborative spirit, are essential. Hiring Manager Title Vice President, Global Medical...Flexible hours
$284.32k - $355.4k
...experienced individual for the position of Senior Medical Director, Clinical Research (Neurology) to join our R&D Organization. This... ...decisions. Responsible for and lead all activities related to clinical study design from study concept to study protocol for both early- and...WorldwideFlexible hours- ...REPORTS TO: Senior Vice President, Head of Clinical Development LOCATION : Boston, MA... ...preferred; and a proven track record in managing global clinical trials. This role is... ...and interpretation of Phase I clinical studies. * Collaborate with cross-functional teams...
$310k - $380k
...also participate, in varying degrees, on clinical teams/programs and other intra and/or... ...medical safety lead on cross-functional study and program teams for assigned products... ...detection practices. Participate in Risk Management Strategy. Other activities, as needed...- ...to the Senior Director, Medical Affairs. This position will lead medical reviews, advisory board planning, and the design and monitoring of US-based clinical studies, collaborating with Medical Information, MSLs, and the Grants/Communications teams. #J-18808-Ljbffr...
$311k - $388.5k
...progress because of the high cost and time of clinical trials. Recognizing that this development... ...and clinical pharmacology studies needed to support NDA and drug label Lead... ...effectiveness of clinical pharmacology studies Manage resources, timelines, and budget for...Work at officeLocal areaRelocation3 days per week$220k - $245k
...Director, Clinical Science Olema Oncology is a clinical-stage biopharmaceutical company... ...key role in one of our ongoing clinical studies. You will work collaboratively in a... ...Clinical Operations, Medical Monitors, Data Management, Biostatistics, Clinical Pharmacology, Regulatory...Work at officeFlexible hours- ...partners, and advocacy groups in all of our clinical and regulatory development strategies.... ...in the diagnosis, treatment and management of targeted disease areas and associated... ...payer materials. Lead and support clinical studies and evidence generation activities including...Local areaFlexible hours
$232k - $348k
...General Summary: The Senior Director, Clinical Pharmacology will serve as a Disease Area... ...Director, Clinical Pharmacology will also manage the scientific functions and coordinate... ...execute Clinical Pharmacology plans and studies for Disease Area programs * Directs Clinical...Summer workRemote workFlexible hours2 days per week- ...Senior Director, Clinical Pharmacology Description Reporting to the SVP of Research... ...biomarker development and biodistribution studies, and will be accountable for delivering... ...of innovation and scientific rigor Manage CROs and translational scientists that will...Work at office3 days per week
$313k - $366k
...Executive Director, Oncology Clinical Sciences The Executive Director, Oncology Clinical... ...registrational development and lifecycle management. This role is intentionally designed for... ...strategy inputs, data review, and clinical study reports. Promote rigorous adherence to...Temporary workFlexible hours$118.34k - $177.51k
...their most challenging cases, with a future vision of accelerating clinical trials, discovering new microbes, and reducing patient... ...is no longer a major threat to human health. The Clinical Sales Manager is responsible for the sales efforts of Karius in a defined regional...Remote jobFull timeLocal areaImmediate startWorldwide$310k - $328.5k
## Senior Medical Director, Clinical SafetyApplyremote type: OnSitelocations: MA-Cambridgetime... ...and medical oversight of all ongoing studies* Lead SAE/SUSAR medical assessment,... ...Affairs* Own safety signal detection and management, including aggregate safety review and signal...Worldwide$131k - $187k
...Senior Clinical Data Manager Repertoire Immune Medicines is a clinical-stage biotechnology company harnessing the power of the human immune... ...activities, including approval of database change requests during study conduct. Ensure eCRF design and database structure...Temporary workWork experience placementWork at officeLocal areaFlexible hours2 days per week3 days per week$177.7k - $240.3k
...Overview The Associate Director (AD), Clinical Science will be a member of the global clinical... ..., medical safety director, safety manager, and clinical pharmacologist) to support... ...the AD, Clinical Science may assist with study design, contribute to the protocol concept...Flexible hours$145k - $160k
...Clinical Data Manager Burlington, MA MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central... ...aspects of clinical trial data management activities from study start-up to database lock. Develop and implement data management...Temporary workWork at officeFlexible hours3 days per week- ...implementation of early and late-stage clinical projects and ensure that the overall scientific... ...protocols, development plans, and study updates to internal governance committees... ...and analyses in collaboration with Data Management and Biostatistics and Statistical...
- ...Job Title PROMETRIKA is a full-service clinical research organization (CRO) with... ...experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance... ...for all Data Management tasks from study start-up to database lock for assigned...Work experience placement
$235k - $330k
...Who we are: Kymera is a clinical-stage biotechnology company pioneering the field of... ...leadership role responsible for overseeing and managing all aspects of clinical operations for... ...plans, including but not limited to, study protocols, clinical trial budgets, timelines...Local area- ...Senior Director Of Clinical Operations The Senior Director of Clinical Operations oversees... ...and ensures that the company achieves study goals and objectives while maintaining... ...including clinical development, project management, regulatory, quality, finance, and translational...Remote work
- ...Senior Medical Director, Clinical Development, Endocrinology At Regeneron, we use science and innovation to develop life-changing medicines... ...clinical trials and are responsible for the design of clinical study concepts leading to clinical trial protocols and oversight of...Worldwide
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