Rangam · 13 hours ago
RCI-ABBV-32090 Clinical Trials Operation Manager (Drug Development) (pharma/Biotech)
United States
Contract
Remote
Entry, Mid Level
$50/hr - $52/hr
1+ years expRangam is seeking a Clinical Trials Operation Manager to join their Clinical Development team. The role involves managing multiple digital projects related to clinical trials, collaborating with various stakeholders, and ensuring adherence to regulations and quality standards in digital health tools.
ConsultingInformation TechnologySoftwareStaffing Agency
Hiring Manager
Sumit Rawat
Responsibilities
Support Digital Strategy Lead in the development of digital strategy and novel endpoint and provide input in the patient insight research, technologies evaluation, usability testing, vendor qualification, and validation of digital health tools for use in clinical trials
Collaborate with medical colleagues and Therapeutic Areas to implement digital strategies, aligned to asset strategy that generates high-quality evidence suitable to support decision making, label enhancement, or market access
Support analytical validation studies of digital tools, adhere to PFDD, DDTQ, CTTI guidances as well as other relevant federal and international regulations, including GCP, ICH Guidelines, Client Standard Operating Procedures (SOPs), and to functional quality standards. Stay abreast of new and evolving regulations, guidelines and policies related to digital health and clinical development
Work with internal and external partners, including vendors, BTS, procurement, regulatory, legal, and QA to enable the qualification of selected digital health tools
Manage multiple digital projects with people and project management skills, e.g. create project plans, trackers, monitor scope, budget, timeline, and report milestones/progress
Identify business needs and support the creation of reports, SOPs, publications
Qualification
Required
Solid understanding of the drug development process and ICH, GCP requirements, with experience in clinical development, data management, health outcome research, or regulatory science
Must have exp. with clinical trials (Trial I-IV)
This is a clinical operation role
Min. educational qualification: BS
Able to manage multiple projects
Must have exp. with clinical trials
Must have exp. with project management
Cross multiple therapeutic area
This person needs to collaborate with study teams
Must have a good communication skills (Written/Verbal)
Must have good understanding of Usability testing, Vendor contracts, Site start-Ups
Patient focused exp. is something they are looking for
Must have 1-3 years of clinical trials exp
Prior pharma industry exp. is required
Clinical trial manager/Clinical Operation Manager have exp. with Phase I-IV exp. would be considered as good fit
Bachelor's, preferred graduated training in life science, clinical, public health or related field with 1-3 years (BS) of relevant experience in the pharmaceutical, healthcare, consulting, or medical device industry
Proficient in project management tools, e.g. Microsoft project, Planisware, smartsheet
Methodical, detail-oriented with the ability to organize and manage multiple projects, as well as collaborate and influence cross-functionally
Demonstrate critical thinking, value-evidence mindset, and problem-solving skills
Strong communication skills in verbal and writing with ability in
Self-starter, ability to navigate a highly complex and matrixed organization
Preferred
Drug development exp. would be nice to have
Prior digital strategy exp. would be helpful but not mandatory
PMP certification would be a plus but not a deal breaker
Manager is open to consider a person with Master's/PhD/PharmD if the person is fine with the pay
Expertise in slide creation would be a plus
Company
Rangam
Rangam is a global, innovative, Total Talent management firm with the mission of accelerating meaningful employment for everyone! We are a minority-, woman-, and disability-owned firm with over 25 years of experience promoting sustainable and inclusive talent programs within our communities and employers.
501-1000 employees
H1B Sponsorship
Rangam has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (2)
2023 (4)
2022 (5)
2021 (4)
2020 (9)
Funding
Current Stage
Late StageLeadership Team
Nish Parikh
Co-founder & CEO
Hetal Parikh
Co-Founder & President
Company data provided by crunchbase