Sr. ClinPharm Clinical Trial Manager

2 weeks ago

Burlington, United States Cardurion Pharmaceuticals, Inc Full time
Job DescriptionJob DescriptionDescription:

Why join Cardurion Pharma?

At Cardurion, we are advancing the understanding of the cellular mechanisms that regulate heart function and are developing new treatments to address cardiovascular disease. Our programs seek to modulate signaling pathways that regulate heart cell function to reverse the pathophysiological mechanisms that drive cardiovascular disease. We invite you to explore our site to learn more about our Company and how we are advancing the promise of cardiovascular signaling pathways science to improve health and impact lives around the world.


The Role:

We are seeking a highly motivated, goal-oriented team player to join Cardurion’s Clinical Operations team as Sr. ClinPharm Clinical Trial Manager (Sr. CTM). The Sr. CTM will be primarily responsible for leading Clinical Pharmacology trials and effectively executing on one or multiple trials in collaboration with functional subject matter experts and CRO(s) to deliver successful operational outcomes. The Sr. CTM is accountable for the day-to-day operational oversight of one or more Clinical Pharmacology trials including study start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity typically is coordinated in conjunction with one or more Contract Research Organizations (CROs). The Sr. CTM exhibits strong teamwork, a positive attitude, and values bringing important medicines to patients in need.


Position can be hybrid in Burlington, MA or remote.


Here’s What You’ll Do:

  • Leads the multidisciplinary study execution team and collaborates with other functions as required for implementation and execution of the study(s)
  • Serves as the primary Clinical Operations point of contact for cross functional team members and CROs, as appropriate.
  • Devises efficient, effective clinical trial execution strategies; guides planning and execution of clinical studies, including management of study budgets / timelines and external vendor(s) management.
  • Prepares and/or reviews/approves study-related documents including, but not limited to, Protocols, Informed Consents (ICFs), study plans and manuals, CRF Completion Guidelines, Clinical Study Report (CSR), and NDA submission documentation, as appropriate.
  • Prepares metrics and updates for Leadership, as appropriate.
  • Proactively identifies, negotiates, and successfully engages the study team in the resolution and/or mitigation of clinical study risks, issues, and challenges and escalates to leadership when appropriate.
  • Participates in CRO/vendor Request for Proposal (RFP) and selection process for outsourced activities
  • Manages CRO/Clinical Service Providers (CSPs) interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, Trial Master File)
  • May serve as a line manager to one or more Clinical Trial Managers (CTMs) and/or Clinical Trial Assistants (CTAs)
  • Participates in the development, review and implementation of departmental SOPs and processes, including development and/or review of templates, tools, and training materials
  • Organizes, leads, and manages internal team meetings, investigator meetings and other study-specific meetings as appropriate

Here’s What We’ll Bring to the Table:

  • Highly competitive package with healthcare coverage including medical, dental and vision
  • Fully funded Healthcare Savings Account for high-deductible PPO Plan
  • 4 weeks paid time off annually
  • 10 company paid holidays and year-end shut down
  • 401k (traditional and Roth offered) with company match
  • A suite of Cardurion paid insurance coverage, including life insurance, short-term and long-term disability
  • Flexible spending accounts for medical and dependent care expenses
Requirements:

Here’s What You’ll Bring to the Table:

Core Competencies

  • Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
  • Experience leading previous Clinical Pharmacology studies, such as hADME, DDI, impairment and healthy volunteer studies.
  • Possesses a broad view of the departmental goals and sees the “big picture” scientifically and strategically.
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks under limited direction
  • Effective time management and organization skills with ability to multi-task and shift priorities quickly while working under tight deadlines
  • Must have excellent interpersonal, written and verbal communication skills
  • Skilled in developing collaborative internal and external relationships
  • Ability to effectively communicate, collaborate, and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.

Qualifications

  • BS or BA in a relevant scientific or health related field
  • A minimum of 7 years of related work experience in the pharmaceutical or biotechnology industry, with at least 4 years in a study management role.
  • Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
  • Experience in managing CROs and external vendors
  • Demonstrated proficiency in MS Office (Outlook, MS Word, Excel, PowerPoint); MS Project a plus
  • Some travel may be expected for this position including internal meetings, conferences or training events

Our Mission:Translate our world-class expertise in cardiovascular signaling pathways into groundbreaking therapeutics for patients.
Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Cardurion will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

  • Clinical Trial Manager

    2 weeks ago

    Burlington, United States Cardurion Pharmaceuticals, Inc Full time

    Job DescriptionJob DescriptionDescription:Why join Cardurion Pharma?At Cardurion, we are advancing the understanding of the cellular mechanisms that regulate heart function and are developing new treatments to address cardiovascular disease. Our programs seek to modulate signaling pathways that regulate heart cell function to reverse the pathophysiological...

  • Clinical Trial Manager

    2 weeks ago

    Burlington, Massachusetts, United States Cardurion Pharmaceuticals, Inc Full time

    Job DescriptionCardurion Pharmaceuticals, Inc is seeking a highly motivated and experienced Clinical Trial Manager to join our Clinical Operations team. As a Clinical Trial Manager, you will be responsible for the successful execution of clinical trials, ensuring that all studies are conducted in accordance with regulatory requirements and company...

  • Senior Clinical Research Manager

    2 months ago

    Burlington, Massachusetts, United States Cardurion Pharmaceuticals, Inc Full time

    Job OverviewWhy Choose Cardurion Pharmaceuticals, Inc?At Cardurion, we are dedicated to enhancing the understanding of the cellular mechanisms that govern heart functionality and are pioneering innovative therapies to combat cardiovascular diseases. Our initiatives aim to modulate signaling pathways that influence heart cell performance, reversing the...

  • Senior Manager, Clinical Drug Supply

    2 weeks ago

    Burlington, United States Cardurion Pharmaceuticals, Inc Full time

    Job DescriptionJob DescriptionDescription:Why join Cardurion Pharma?At Cardurion, we are advancing the understanding of the cellular mechanisms that regulate heart function and are developing new treatments to address cardiovascular disease. Our programs seek to modulate signaling pathways that regulate heart cell function to reverse the pathophysiological...

  • Clinical Data Manager

    1 month ago

    burlington, United States Catalyst Life Sciences Full time

    We are partnering with a biotechnology group to find a clinical data manager on a contract basis. It will most likely be for 3-months, but there is a chance of extension. This person will be in charge of data review, cleaning, and reporting. This candidate will be expected to come into the office one day per week in Burlington, MA.You should apply if you...

  • Clinical Program Consultant Sr.

    3 days ago

    Burlington, Vermont, United States Cambia Health Solutions Full time

    About the RoleCambia Health Solutions is seeking a highly skilled Clinical Program Consultant Sr. to join our team. As a key member of our Transformation, Quality, and Learning team, you will play a critical role in facilitating strategy development, planning, and business development efforts to advance our Clinical Mission.Key ResponsibilitiesAnalyze key...

  • Lead Clinical Data Manager with oncology experience

    2 weeks ago

    Burlington, United States Team-Soft, LLC Full time

    Note: No sponsorship for this position at this point.As a Lead Clinical Data Manager with oncology experience, you play a pivotal role in the management of clinical trial data specific to oncology studies. Study Design and PlanningProtocol Review: Collaborate with study teams to review and understand clinical trial protocols, particularly focusing on...

  • Clinical Program Consultant Sr.

    4 weeks ago

    Burlington, Vermont, United States Cambia Health Solutions Full time

    About the RoleCambia Health Solutions is seeking a highly skilled Clinical Program Consultant Sr. to join our team. As a key member of our Transformation, Quality, and Learning team, you will play a critical role in facilitating strategy development, planning, and business development efforts to advance our Clinical Mission.Key ResponsibilitiesAnalyze key...

  • Clinical Research Director

    4 weeks ago

    Burlington, Vermont, United States InsideHigherEd Full time

    Join Our Team as a Physician-Scientist/Academic ClinicianWe are seeking a highly skilled physician-scientist/academic clinician to serve as Associate Director of Clinical & Translational Research in our Division of Hematology/Oncology. This position involves approximately 50% clinical effort with remaining effort protected for scholarly activities. The...

  • Clinical Research Director

    4 weeks ago

    Burlington, Vermont, United States InsideHigherEd Full time

    Join Our Team as a Physician-Scientist/Academic ClinicianWe are seeking a highly skilled physician-scientist/academic clinician to serve as Associate Director of Clinical & Translational Research in our Division of Hematology/Oncology. This position involves approximately 50% clinical effort with remaining effort protected for scholarly activities. The...

  • Sr. Accountant

    2 weeks ago

    Burlington, United States Robert Half Full time

    Job DescriptionJob DescriptionWe are offering a contract to hire employment opportunity for a Sr. Accountant in Burlington, Massachusetts. This role calls for an individual with a strong background in the financial industry, capable of fulfilling both remote and on-site work requirements. As a Sr. Accountant, you will be entrusted with key tasks such as...

  • Director of Clinical Quality Assurance

    2 weeks ago

    Burlington, Massachusetts, United States Cardurion Pharmaceuticals, Inc Full time

    Job Title: Director, Clinical Quality AssuranceCardurion Pharmaceuticals, Inc is seeking a highly experienced Director, Clinical Quality Assurance to join our team. As a key member of our Quality Assurance department, you will be responsible for developing, maintaining, and executing the requirements of our Quality Systems as they pertain to clinical...

  • Director, Clinical Quality Assurance

    3 weeks ago

    Burlington, United States Cardurion Pharmaceuticals, Inc Full time

    Job DescriptionJob DescriptionDescription:Why join Cardurion Pharma?At Cardurion, we are advancing the understanding of signaling pathways that regulate heart cell function. Our programs seek to modulate these pathways to reverse the pathophysiological mechanisms that drive cardiovascular disease. We invite you to explore our website to learn more about our...

  • Sr. Kitchen Utility Worker

    3 weeks ago

    Burlington, United States JobsRUs.com Full time

    Join the JobsRUs.com Team as a SrKitchen Utility Worker in Burlington, VT! Pay: $15.25/hrHours: 8-hour shifts, 40 hours/weekContract: 1 yearRole: As a SrUtility Worker, you'll lead the charge in maintaining clean and organized kitchen areasYour tasks will include washing dishes, cleaning workstations, managing waste, and directing lower-level staff.General...

  • RN Psychiatric Assistant Manager

    1 day ago

    Burlington, United States Clinical Management Consultants Full time

    Are you ready to take the next step in your nursing career? Our client, a highly reputable and award-winning hospital in the Central Vermont area, is seeking a talented and experienced RN Psychiatric Assistant Manager to join their team. This hospital, located in the heart of scenic Central Vermont, offers a unique and rewarding work environment. Join us and...

  • Medical Laboratory Technologist Trainee

    1 week ago

    Burlington, North Carolina, United States Crescent City Recruitment Group Full time

    Job Title: Medical Laboratory Technologist TraineeThis is a contract job opportunity for a Medical Laboratory Technologist Trainee. The position is located in Burlington, NC, and the schedule is 8am - 4:30pm, Monday to Friday, with no weekends required. However, there is some room for flexible scheduling, and the company is open to discussing alternative...

  • Sr. Customer Assistance Representative

    5 months ago

    Burlington, United States Enterprise Holdings Full time

    Overview Enterprise Mobility operates the Enterprise Rent-A-Car, National Car Rental, and Alamo car rental brands and has frequently been named one of the top places to work. Enterprise Mobility is the largest and fastest growing privately owned automotive rental and leasing company in North America and we are hiring now! We are working towards our...

  • Customer Service Representative Sr

    6 days ago

    Burlington, Vermont, United States Enterprise Holdings Full time

    Job Title: Customer Service Representative SrEnterprise Holdings is seeking a highly skilled and customer-focused Customer Service Representative Sr to join our team. As a key member of our branch team, you will be responsible for providing exceptional customer service, supporting internal and external customers, and ensuring a seamless rental...

  • Gastroenterology- Assistant

    5 months ago

    Burlington, United States The University of Vermont Health Network Full time

    The Robert Larner MD College of Medicine at the University of Vermont and the University of Vermont Medical Center are leaders in patient care, medical education and research. The Department of Medicine has initiated a search for a faculty position at the Assistant/Associate Professor level, Clinical Scholar Pathway, in the Division of Gastroenterology and...

  • Gastroenterology-Assistant/Associate/Full Professor, Clinical Scholar Pathway

    5 months ago

    Burlington, United States The University of Vermont Health Network Full time

    The Robert Larner MD College of Medicine at the University of Vermont and the University of Vermont Medical Center are leaders in patient care, medical education and research. The Department of Medicine has initiated a search for a faculty position at the Assistant/Associate Professor level, Clinical Scholar Pathway, in the Division of Gastroenterology and...