Clinical Research Nurse enhancing pediatric oncology care at Monash Children's Hospital. Collaborating with medical staff and managing patient flow for effective cancer treatment.
About the role
- Clinical Scientist performing medical and scientific data review for haematology clinical trials at Syneos Health. Supporting lead scientists and managing project scopes to ensure deliverables.
Responsibilities
- Perform medical and scientific data review on haematology clinical trials (indication anticipated myeloma or lymphoma)
- Standard data listing review (data listings, AEs, con meds, etc.)
- May complete patient profile review, standard listing data review, efficacy review and safety narrative review, PD analysis and PD review
- Will support Lead Scientist with scientific data review of clinical trial
- May support with additional CS tasks beyond scope of data review at the discretion of the Lead CS team however the primary role will be scientific data review
- Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan)
- Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans
- Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews
- Authors medical data queries and reviews query responses, approves query closure in association with Medical Director
- May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed
- Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed
- Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met
- Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review
- Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety
- Escalates ongoing and newly developed study concerns such as at-risk project deliverables and out of-scope tasks to the project leads in a timely manner
- Attends at Trusted Process meetings and may participate in internal and external audits
- Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology
- Adheres to all data privacy guidelines, ICH, and GCPs, all enterprise policies, standard operating procedures, work instructions, and project plans
- Adheres to customer policies and standard operating procedures, as required in project plans
Requirements
- Degree in life sciences (MSc, PharmD, PhD, DMD, MD) or equivalent with relevant scientific experience and/or training discipline
- Excellent time management skills to handle multiple tasks and meet deadlines while delivering high quality work in a highly regulated and dynamic environment
- A self-starter and comfortable with fluctuating timelines, work demands and changes in scope of work
- Ability to troubleshoot situations as needed and understands when issues or questions need to be escalated to the leadership
- Understanding of scientific principles to assure effective and high-quality medical data analysis
- Excellent written and oral communication skills
- Excellent computer skills: MS Office programs, spread sheets, presentations
- Prefer knowledge of drug development and demonstrated proficiency with ICH/GCP guidelines
- Strong team player with excellent interpersonal skills and ability to work effectively in a cross-functional team environment.
Benefits
- career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
- Total Self culture
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Senior Clinical Trial Manager overseeing site management and monitoring for biopharmaceutical solutions organization. Responsible for clinical monitoring, patient safety, and regulatory compliance in South Africa.
Associate HR Partner supporting employee operations at CPS Clinical Research Units. Providing HR guidance and managing employee relations in a clinical environment with on - site presence.
Clinical Research Study Assistant involved in Alzheimer's disease research collecting samples and data. Participating in study protocols and maintaining participant interactions.
Oncology Clinical Research Coordinator at WVU managing clinical trials and ensuring protocol compliance. Collaborating with research staff and healthcare providers while advocating for ethical participant care.
Clinical Research Coordinator supporting clinical research for pediatric care at Shriners Children’s. Ensuring compliance with research protocols and collaborating with clinical teams in Pasadena.
Clinical Research Coordinator managing aspects of clinical trials at Winship Cancer Institute. Handling data management, participant interface, and overseeing trial compliance in Atlanta.
Feasibility Manager at Novo Nordisk optimizing clinical trials through data analysis and strategic partnerships across South Africa. Driving site selection and operational readiness for impactful clinical development.
Clinical Research Coordinator managing overall coordination and implementation of clinical trials. Collaborating with investigators to ensure compliance with study protocols and maintaining accurate subject records.
Clinical Research Coordinator independently managing key aspects of clinical trials. Overseeing data management and ensuring compliance with study protocols and regulations.