10 Jobs
Dragonfly Therapeutics is Hiring a Clinical Trial Manager Near Waltham, MA
Dragonfly Therapeutics seeks a Clinical Trial Manager with relevant Clinical Operations experience to join our Clinical Development group and who will be responsible for providing trial management support for our cancer immunotherapy programs. This role will report to the Sr. Director, Clinical Operations. Job responsibilities include, but are not limited to, preparation of study related materials, enrollment tracking and reporting to clinical development leadership, relationship management between study sites and vendors (in particular CROs), supervision of study related activities, identification of project risks, and contingency planning.
Responsibilities:
- Primary operational contact for execution of the study in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions
- Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders
- Lead weekly meeting of the Clinical Trial Team on status of assigned studies.
- Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
- Operational input into study documents such as synopsis, protocol, Informed Consent Forms, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, etc.
- Participation in clinical service provider (vendor) selection, specification development, and management/oversight
- Development/coordination of study training for study team, investigational sites, and vendors in collaboration with medical and scientific colleagues
- Proactive management of issues and information sharing with key internal/external stakeholders with use of standardized reports and other mechanisms.
- Lead both an internal and external/CRO trial management team, to ensure the successful conduct of the trial in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs
- Manage and lead site-facing meetings, including regular PI meetings, dose escalation meetings, and Investigator Meetings
- Attend study site visits, such as pre-study selection visits, site initiation visits, and PI engagement meetings
- Contribute to development of proactive strategy and corrective action plan to address trial issues in collaboration with cross functional team
- Responsible for supporting the management, oversight (CRO) and maintenance of the Trial Master File (TMF)
- Bachelor's degree, or equivalent, in a biomedical, life science or related field of study
- Minimum of 3 years of progressively increasing Clinical Operations experience within the Pharma, Biotech or CRO industry; Oncology/Immuno-oncology or immunology/inflammation experience required
- Good understanding of US regulatory and compliance requirements for clinical research
- Solid teamwork, organizational, interpersonal, and problem-solving skills; exercises good judgment with respect to confidential information and strategies
- Can communicate effectively
- Ability to influence and collaborate well with colleagues and partners in a fast-paced environment
- Ability and willingness to travel up to 15% of time
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.
Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.
Job Summary
Full Time
$105k-137k (estimate)
04/30/2024
05/19/2024
dragonflytx.com
CAMBRIDGE, MA
100 - 200
2015
BILL HANEY
<$5M
Scientific Services
Related Companies
The following is the career advancement route for Clinical Trial Manager positions, which can be used as a reference in future career path planning. As a Clinical Trial Manager, it can be promoted into senior positions as a Clinical Research Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Trial Manager. You can explore the career advancement for a Clinical Trial Manager below and select your interested title to get hiring information.
If you are interested in becoming a Clinical Trial Manager, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Clinical Trial Manager for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Clinical Trial Manager job description and responsibilities
Presented overall audit to clinical policy and oversight committee and departmental managers.
02/14/2022: Erie, PA
Before a medical treatment can be administered to the general population, a clinical trial manager needs to oversee a test study.
03/03/2022: Pine Bluff, AR
Clinical trial managers make sure all aspects of clinical trials meet regulatory requirements and scientific standards while protecting patient safety.
02/24/2022: Santa Ana, CA
Clinical Trial Managers are responsible for executing and supervising clinical trials using effective organizational strategies.
03/24/2022: Alamogordo, NM
Learn more about the requirements, responsibilities, training, salary, and job outlook of Virtual Clinical Trial Managers.
01/29/2022: Florence, SC
Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Clinical Trial Manager jobs
Communication, feedback, and mentoring are part of a clinical trial manager's job.
02/21/2022: Riverside, CA
Clinical trial managers also hire, train, and evaluate the members of the clinical team.
01/23/2022: Flagstaff, AZ
Without a Clinical Trial Manager to select projects and balance speed with safety, Physicians would waste time researching low-demand medications while putting lifesaving medicines on hold.
04/05/2022: Battle Creek, MI
A clinical trial manager must also possess effective leadership abilities.
03/24/2022: Bangor, ME
Clinical Trial Managers must possess excellent communication skills, leadership ability and multitasking personality.
04/01/2022: Springfield, MA
Step 3: View the best colleges and universities for Clinical Trial Manager.
