SENIOR CLINICAL TRIALS MANAGER

2 weeks ago

MA United States Clinical Dynamix, Inc. Full time
Role: Clinical Trial Manager / Senior Clinical Trial Manager

We are looking for a energetic and passionate Clinical Trial Manager / Senior Clinical Trial Manager who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharma company. The CTM/Sr.CTM leads activities to oversee the conduct of clinical research at Company Pharmaceuticals in accordance with FDA, EMA, GCP, and ICH guidelines. This role will be responsible for collaborative oversight of cross-functional study team activities, as well as exceptional management of external vendors and stakeholders (e.g., CROs, central labs, IRBs/ECs, and other external partners).

Who are we looking for?
• You have been working effectively in an independent trial management role for at least a year and are looking for an invigorating role where you can work autonomously on a high profile company trial to execute study deliverables with quality.
• You are an energetic and passionate Clinical Operations professional who likes to think outside of the box, proactively seeks out and recommends process improvements and is passionate about the company's mission of discovering and developing new medications
• You are a resourceful self-starter and team player with a strong results orientation
• You are open and authentic and can develop trusting relationships to move projects forward despite challenges.
• You act like an owner and take accountability; you are reliable
• You are resourceful and apply critical thinking to solve problems and add value to the Clinical Development team
• You have strong written and verbal communication and know how to seek clarity in ambiguous situations

What are we looking for?
• A driven professional who is comfortable supporting the development of procedures in parallel with doing the work
• A collegial team player who enjoys working in close collaboration with external vendors and teams; someone who understands the criticality of vendor partnerships for the execution of clinical trial conduct
• A person who thrives in a small company atmosphere and is willing to roll up their sleeves to support all aspects of clinical trial execution
• A person who acts with a sense of urgency and a quality-mindset

What are we offering?
• Membership within a growing, supportive, highly connected and collegial organization
• Being part of passionate, involved, fun and cutting-edge Clinical Development Team - the ability to wear multiple hats and gain exposure to many aspects of the business
• Ability to develop within Clinical Development Operations under strong mentorship
• Exposure to pioneering science and the discovery of drugs to help treat patients with cancer

What you will do:
• Leads the activities of the protocol level team as it relates to study-level strategy, timelines, goals, and quality; Liaises with cross functional team members for coordination of clinical study support to include but not limited to drug supply management, quality management, regulatory management initiatives
• Evaluates, selects and ensures appropriate oversight of Contract Research Organizations (CROs) and other external vendors. Builds solid relationships with key counterparts at CRO(s) and other external vendors
• Coordinates the development and distribution of critical study documents, including Informed Consent Forms, operational documents, study reference documents, site materials, trainings and other study related documents; supports the development of clinical study protocols, clinical study reports and other documents as needed
• Communicates with clinical trial sites as appropriate to ensure optimal Sponsor-Site relationships
• Drives site start-up, subject enrollment, clinical monitoring, site and vendor compliance activities and data metrics from CROs and other external vendors.
• Communicates trial status within and outside the study team to ensure cross-functional alignment of expectations, priorities, and deliverables
• Develops and manages the study-level budget(s) and demonstrates accountability for the management of the budget through facilitation of WOs, CNFs and change orders according to study needs and tracking vendor performance against scopes of work, contracts, and invoices; manages budget forecasting and accruals in collaboration with Company FP&A.
• Analyzes clinical study and investigative site risks and implements corrective actions, where required
• Provides oversight of the applicable study drug(s) including supply projections, and partners with the Clinical Supply Chain for study drug distribution, labeling and destruction
• Performs quality assurance checks (e.g. reviewing protocols for operational effectiveness, monitoring trip reports for potential gaps in site/CRA training, conducting co-monitoring visits at clinical sites, reviewing data listings at interim analysis milestones)
• Supports and collaborates with GCP QA during site/study audit and vendor selection/auditing activities
• Leads Clinical Operations preparation of inspection readiness activities for FDA and other applicable regulatory body audits and/or meetings
• Owns the Trial Master File for assigned trials; ensures appropriate quality oversight and QC of required elements of TMF
• Maintains internal document repositories (e.g. Sharepoint)
• Assists with identifying and implementing best practices and continuous improvement plans within the company
• Participation in SOP, work instruction, and/or template development and review, as required
• Performs administrative functions and additional duties as assigned and appropriate

What you will bring:
• A deep understanding of Clinical Operations and trial management
• A willingness to learn new things, adapt to new ways and go with the flow
• An ability to determine priority and risk associated with study decisions
• A positive, can-do attitude and a team mindset
• An interest in your own personal development

Our values:

Transparency: We work with honesty, openness, and integrity.

Community: We collaborate and thrive together.

Patient-Focused: We are committed to finding new medicines for patients.

Resolve: We never give up on our mission.

When You Join US You Will Have: Work from home, one day a week in office- Flexible
• Location reachable by public transportation (Red Line)
• Customized and competitive health coverage, including medical offered through BCBS (HMO/PPO), dental, and vision
• Health Savings Account for medical expenses
• Eligible from the first day for 401K with 100% match of the first 5%
• A robust package of Company-paid insurance coverage, including life insurance, short-term and long-term disability
• Unlimited time off and 11 Holidays
• Winter Break: Company is closed for a Winter Break between Christmas and New Year

Location: Cambridge (Kendall Square), MA

  • Clinical Trial Lead

    4 weeks ago

    Boston, MA, United States Joulé Full time

    Title: Clinical Trial Lead Location: Boston, MA. Start Date: ASAP! Duration: Contract-to-Hire Hours: Mon-Fri; 8:30am-5pm Overview Our client is a hospital which is internationally-known referral center for the most complex cases in nearly all areas of medicine. Some of their specialty areas include: Cancer, Heart, and Vascular. Requirements: BS degree...

  • Senior Clinical Finance Manager

    6 days ago

    CAMBRIDGE, MA, United States Novartis Full time

    About the roleThis role is located at our Cambridge, MA site and will not have the ability to be located remotely.CS&I is a dynamic group of Clinical Scientists who plan and execute Novartis’ early phase global clinical trials. From First-in-Human, to Proof-of-Concept, and beyond, we design and operationalize clinical trials, ensuring they run smoothly, on...

  • Clinical Trials Research Registered Nurse, Clinical Trials, FT, 8A-4:30P

    8 hours ago

    Miami, FL, United States Baptist Health South Florida Full time

    The Clinical Trials Nurse effectively conducts assigned operations of research protocols. Coordinates, evaluates and follows patient participation in clinical trials. Performs protocol specific clinical tasks including patient assessment, screening, ordering tests, collecting specimens and monitoring responses to the investigational treatment. Implement the...

  • Project Director, PCORI Clinical Trial

    6 days ago

    Boston, MA, United States Mass General Brigham Full time

    DescriptionGENERAL SUMMARY/ OVERVIEW STATEMENT:  The Center for Aging and Serious Illness (CASI) within the Mongan Institute and affiliated with the Division of Palliative Care and Geriatric Medicine is seeking a PhD or Masters-level project director with training and experience in multi-site clinical trials to oversee a large comparative effectiveness...

  • Senior Scientist, Clinical Biomarkers

    4 days ago

    Boston, MA, United States Meet Full time

    140000 USD - 180000 USD Boston , United StatesPermanentJob Title: Principal Scientist, Clinical BiomarkerCompany Overview: Join a dynamic and forward-thinking mid-sized biotech company dedicated to advancing breakthrough therapies and diagnostics in the field of life sciences. Our client's innovative research and collaborative approach drive meaningful...

  • Clinical Trial Protocol Coordinator

    3 weeks ago

    Boston, MA, United States Joulé Full time

    Title: Clinical Trial Protocol Coordinator Location: Boston, MA Hybrid schedule Start Date: ASAP Duration: 6 Month Contract-to-Hire Hours: Mon-Fri, 8am-4:30pm Requirements: BS degree in Life Sciences or related 1-2 yrs. research exp. in a Pharma, CRO, Biotech and/or Healthcare setting (Co-Op & Internship exp. would count towards this) Willing to do some...

  • WCI CLINICAL TRIALS OFFICE-RESEARCH

    2 weeks ago

    , NY, United States University of Rochester Full time

    ResponsibilitiesThe WCI Clinicals Trials Office (CTO) is seeking a highly motivated and inclusive individual to become a part of our leadership team. This is a great opportunity to mentor and work collaboratively with staff (both nurses and study coordinators) to further develop our clinical trials team within the CTO. This role provides oversight for the...

  • WCI Clinical Trials Office-Research

    2 hours ago

    Rochester, NY, United States University of Rochester Full time

    Responsibilities The WCI Clinicals Trials Office (CTO) is seeking a highly motivated and inclusive individual to become a part of our leadership team. This is a great opportunity to mentor and work collaboratively with staff (both nurses and study coordinators) to further develop our clinical trials team within the CTO. This role provides oversight for the...

  • Associate Manager, Clinical Study

    21 hours ago

    Armonk, NY, United States Regeneron - Willhire Full time

    Associate Manager, Clinical StudyBudgetCase ReportClinical MonitoringClinical StudyClinical TrialCRFDatabaseData ManagementData QualityForecastingReconciliationTrial ManagementDescription:Associate Manager, Clinical StudyPay Range: $50.92 - $83.27/hrHybrid Role in Armonk, NYThe Temp Assoc Mgr Clinical Study will be assigned activities by the CSL,...

  • Wilmot Cancer Center

    4 hours ago

    Rochester, NY, United States University of Rochester Full time

    Responsibilities Seeking a team focused professional with a passion for oncology. This is an exciting opportunity to join the Clinical Trials Office as part of the Wilmot Cancer Center (WCC) within the University of Rochester Medical Center (URMC) as a Clinical Research Nurse (CRN). The CRN works closely with and is guided by the Principal Investigator, to...

  • Senior Clinical Strategist

    6 hours ago

    Boston, MA, United States CVS Pharmacy, Inc. Full time

    Work at home with requirement to reside in or around Springfield, MA. Shift is Monday-Friday standard business hours. No nights, no weekends and no holidays. Travel is approximately 50% in Springfield, MA As the ACO (Accountable Care Organization) RE Clinical, Strategist, Clinic, Senior, Healthcare, Retail, Performance

  • Trial Attorney

    4 weeks ago

    Conley, GA, United States State Farm Full time

    OverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...

  • Trial Attorney

    4 weeks ago

    Decatur, GA, United States State Farm Full time

    OverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...

  • Trial Attorney

    4 weeks ago

    Smyrna, GA, United States State Farm Full time

    OverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...

  • Trial Attorney

    4 weeks ago

    Tucker, GA, United States State Farm Full time

    OverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...

  • Trial Attorney

    6 days ago

    Atlanta, GA, United States State Farm Full time

    OverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...

  • Trial Attorney

    6 days ago

    Clarkston, GA, United States State Farm Full time

    OverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...

  • Trial Attorney

    5 days ago

    Mableton, GA, United States State Farm Full time

    OverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...

  • Trial Attorney

    4 weeks ago

    morrow, GA, United States State Farm Full time

    OverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...

  • Trial Attorney

    3 weeks ago

    Marietta, GA, United States State Farm Full time

    OverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...