Clinical Scientist executing and supporting clinical trials at Oruka Therapeutics. Collaborating with teams to ensure high - quality data collection and analysis for chronic skin disease treatments.
About the role
- Senior Clinical Trial Manager overseeing operational aspects of clinical studies at Scholar Rock. Implementing project plans and coordinating team activities throughout the study lifecycle.
Responsibilities
- Implement clinical project plans in accordance with key study documents (e.g. protocols, project plans and timelines, etc.) as well as corporate and regulatory objectives
- Facilitate internal project team meetings
- Ensure trial master file (TMF/eTMF) is established, current, and maintained.
- Drive all aspects of study start-up, including CRO selection
- Point of contact for sites, vendors and CROs
- Monitor CRO and vendor adherence to scope of work
- Manage interactions with investigators and investigative sites to ensure activities are conducted in accordance with all regulatory requirements
- Proactively identify, resolve, and escalate issues that jeopardize timely clinical study completion
- Develop and manage clinical trial budget and facilitate contract review
- Participate in vendor, site and CRO audits as appropriate
- Participate in site monitoring visits as necessary
- Plan and present at Investigator Meetings, company, and other meetings as necessary
- Develop internal tracking and reporting tools for reporting study status to Leadership
- Adhere to all department SOPs, GCP/ICH guidelines, and QC/QA procedures
- May require international and domestic travel (up to 20%)
- Other duties and responsibilities as required
Requirements
- BS/BA degree in a scientific discipline; advanced degree preferred
- Minimum of 5+ years demonstrated experience in a biotech/pharmaceutical/ CRO company, clinical research site or related healthcare company
- Prior experience with a multi-phase clinical program or experience across multiple phases of clinical drug development
- Highly organized, outcome oriented, self-motivated performance
- Thrives in a fast-paced and evolving environment
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
- Ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations
- Understanding of the drug development process
- Knowledge of federal regulatory requirements and guidelines for Good Clinical Practice
- Strong written and oral communication skills
Benefits
- Health insurance
- Flexible work arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Clinical Scientist assisting the Clinical Research Director in studies related to asthma and inflammatory diseases. Supporting clinical trial execution and document preparation at a biopharma company.
Head of CRO Channel Sales leading partnerships and direct sales for ProofPilot’s clinical trial solutions. Focused on developing high - impact partnerships within the clinical trial ecosystem.
Clinical Research Coordinator II at University of South Florida responsible for coordinating clinical research activities and ensuring participant data quality. Serving as main contact for sponsors and patients for specific research protocols.
Clinical Research Study Assistant supporting neurology clinical research at WashU. Assisting in data management, document compliance, and coordinating study personnel interactions.
Seeking an Advanced Practice Provider for part - time clinical research role at SRI. Flexible hours supporting studies in Plymouth, MI with potential for growth into longer - term positions.
B(
Clinical Research Coordinator II in Boston managing research studies and patient eligibility tracking. Collaborating with a research team for patient recruitment and data processing in healthcare.
RN Clinical Research Coordinator overseeing successful implementation of oncology clinical research studies at Florida Cancer Specialists. Collaborating with Principal Investigator and team for effective study management.
Clinical Research Study Assistant responsible for participant recruitment and data collection in Radiology at the Gordon Precision Neuroimaging Lab. Ensuring adherence to protocols and quality of information.
Clinical Research Coordinator providing assistance on clinical research studies including recruiting and organizing data. Supporting patient consent and clinical tests within a hybrid work setting.