TRiNDS has an outstanding opportunity for an experienced Senior Clinical Research Project Manager.
TRiNDS is a team of highly skilled project managers, data managers and administrative professionals focused on neuromuscular and rare disease clinical research projects. TRiNDS provides a supportive and inclusive work culture where employees are empowered to own their work, teams are encouraged to have open dialogue and leadership is transparent and communicative. TRiNDS is a telework corporation, having embraced the power of putting the right people together regardless of location.
TRiNDS is seeking a full-time Senior Clinical Research Project Manager. The Senior Clinical Research Senior Project Manager will work under the direction and guidance of the TRiNDS Director of Clinical Operations.
Primary Responsibilities:
- Act as project manager overseeing one or more projects or programs during its complete lifecycle, i.e., tracking and monitoring project finances (i.e., budget and invoices), deliverables, staffing, and timelines.
- Proactively identify project risks, offer risk mitigation strategies and solutions, and work with the TRiNDS Director(s) to resolve any matters.
- Collaborate across TRiNDS solutions where necessary, to support milestone achievement and to manage study issues and obstacles.
- Participate in and/or lead vendor identification, selection, and management.
- Participate in sponsor and/or regulatory audits/inspections.
- Develop and maintain project plans and other study-related materials.
- Plan, conduct, and manage research projects within the federal regulations and policies, as well as TRiNDS quality system documents (QSDs).
- Contribute to new project proposals, including support of bid submission strategy and attendance at bid defense or presentations.
- Ensure regulatory integrity of protocols through oversight and/or preparation of multicenter protocol(s), consent form template(s), protocol amendment(s), and annual progress report(s).
- Ensure site management follows the study plans, regulations, and TRiNDS QSDs.
- Serve as primary point of contact for assigned Sponsors and maintain regular communications with sponsors, vendors, and assigned study teams including lead sponsor, vendor, and/or internal meetings.
- Participate in company-wide activities and contribute to creation and/or modification of relevant TRiNDS SOPs, manuals, templates, or other relevant materials or processes.
- Supervise staff as needed.
- As a manager, foster a culture of process improvement by streamlining workflows, enhancing efficiency, and delivering value to TRiNDS while addressing client needs. Managers are also expected to collaborate closely with Directors and Officers across TRiNDS to align on company vision and goals to ensure unified, consistent management practices that drive organizational success.
- As a member of staff, embrace and contribute to our culture, add value to our business and meet client needs.
Qualification Requirements:
- Master of Science in Clinical Research Administration or other related field, or at least 15 years of relevant clinical research experience.
- Minimum of 10 years prior relevant experience in the academic, industry or relevant clinical research organization including 5 years of prior project management experience or equivalent with pharma/biotech and/or CRO.
- Excellent working knowledge of FDA & ICH/GCP regulations and guidelines.
- Strong organizational skills and attention to detail.
- Ability to travel up to 10%.
- Strong working knowledge of electronic data capture, clinical trial management and trial master filing systems.
- Therapeutic area expertise in pediatrics and/or neuromuscular is highly desirable.
- Detail oriented and fluent in written and oral English.
- Applicants must be legally authorized to work in the US without the need for employer-sponsored visa support, now or in the future.
This position is primarily remote/work from home. The preferred candidate will reside in FL, MD, NC, NH, PA, SC, TN, TX, UT or WA. Some travel may be required for training, Sponsor meetings, oversight monitoring visits, and the annual company retreat.
For consideration, send a cover letter along with your resume.
About TRiNDS (Therapeutic Research in Neuromuscular Disorders Solutions): TRiNDS is a specialized contract research organization (CRO) dedicated to conducting high quality clinical trials in neuromuscular and rare diseases. TRiNDS offers expert dedicated solutions in trial management, clinical monitoring, site management, data management, study outcome measures, and other neuromuscular specific clinical research services. We are uniquely focused on muscular dystrophies, such as Duchenne muscular dystrophy (DMD), and our expertise has been drawn from the academic clinical trial network: The Cooperative International Neuromuscular Research Group (CINRG). TRiNDS bridges gaps for neuromuscular and rare disease clinical trials by engaging with key leaders in the field.
For more information, please visit: www.trinds.com
TRiNDS benefits are highly competitive to attract and retain top talent:
Compensation: We offer competitive compensation packages, inclusive of an individual performance bonus program.
Comprehensive Benefits: We provide a variety of benefits to support your financial security, health and wellbeing including retirement plans, health programs, life insurance and medical care.
Work-Life & Flexibility: We support you in maintaining a balance between working hours and personal life. As a telework company, we offer remote working arrangements in all areas in which we operate.
Training & Development: We are committed to your professional and personal development and encourage you in the ongoing pursuit of education, training, and knowledge through both formal and informal learning.
TRiNDS participates in the E-Verify Program.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Vision insurance
Work Location: Remote
