Clinical Operations Jobs

Director of Clinical Operations

Salary: $215-$250K Company Summary: A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Director of Clinical Operations for a remote role. Their commercial supply of pharmaceutical products has generated upwards of $80 million in Q2 sales. Since their first clinical trial in 2002, they've had 8 approvals already on the market. Currently, they have 12 indications in Phases II and III, so they are looking for a driven, growth-oriented Director to facilitate their clinical programs on a global scale. The Director will be responsible for: * Managing and establishing clinical programs in accordance with the Executive Management Team * Directing and executing clinical programs in accordance with established timelines * Study feasibility assessments, document management, pharmacovigilance, and ethics committee documentation An ideal candidate for this role MUST have… * Bachelor's in biomedical science or medical related field * 5 years of experience in a senior management level role * Working knowledge of ICH GCP guidelines Benefits: * Competitive salary with benefits * Being a part of team whose work directly aims to improve the quality of people's lives * Great work-life balance If you're interested in this role, send an application our way!

Director of Clinical Operations

Director of Clinical Operations

Freelance Clinical Field Manager

EPM Scientific are currently working with an up and coming, small European Medical Device Company with an exciting specialized pipeline seeking a Field Clinical Manager to join their team. See a short summary below; Contract Conditions: Start date: ASAP Location: Europe (Remote) Interviews: As soon as possible Language: English Project: Medical Device, Neurology Key Responsibilities: Developing training materials and a procedure manual for our clinical protocol Conducting in-depth training sessions for all EU sites and physicians involved in the trial Attending as many relevant clinical procedures as possible and providing feedback and support Liaising with engineers, regulatory authorities, and other stakeholders Requirements Strong (5 years or similar) experience in the Clinical field working on Medical Devices International experience with pre-market clinical studies in the EU Ability to travel frequently in the EU and occasionally in the US Master's degree or equivalent ideal If this role is of interest to you, please apply directly to learn more about the role. If not feel free to share with your network.

Germany

US$95 - US$125 per hour + Healthcare,401k

Senior Clinical Trial Manager - Hybrid

A mid-sized, multi-national Biotechnology company headquartered in California is looking to bring an experienced Clinical Trial Manager onto its team. This company focuses on creating products and therapeutics to combat cancer and improve the lives of those living with the disease. This company is working on a proprietary drug platform, with a pipeline boasting multiple early phase studies. To support their growth and abundance of studies, they are looking to add a talented, experienced Clinical Trial Manager to their team. Responsibilities will include but are not limited to: Planning, executing, management, and oversight of Clinical Trials Leading vendor selection/site selection processes Oversees creation of study budget, monitoring, recruitment, and timeline plans Supervise, oversee, and maintain communication with CRO and other third-party vendors Lead the development of study protocols, study SOPs, ICF forms, CRFs, etc. Lead a cross-functional team including clinical operations, data management, regulatory affairs, pharmacovigilance, biostatistics, etc. Execute clinical studies according to ICH/GCP guidelines, FDA regulations, from startup through closeout Keep stakeholders informed of and up to date with study progress/advancement Qualifications include: Bachelor's degree (life sciences preferred) Oncology Trial Management experience in an industry setting is REQUIRED 5+ years clinical research experience, in an industry setting 3+ years Clinical Trial Management experience, in an industry setting An understanding of cross-functional clinical processes Ability to juggle multiple complex tasks at any given time

South San Francisco

Facilities Project Manager

**Onsite Role in Burbank, CA** Job opportunity with a top compliance and consulting organization company that is looking for a Project Engineer to join their team on a 12-24 month contract with an opportunity for conversion or extension! Qualifications: Education: BS/MS degree required. An advanced degree in Chemical, Mechanical or Biomedical Engineering is a plus. 10-15 years' experience in a regulated, manufacturing environment within the biotechnology or pharmaceutical industry. A minimum of 5 years of experience overseeing and implementing technical engineering projects is a requirement. Experience with facilities, utilities, and processing equipment. Examples include vessels, tanks, centrifuges, filter press, clean in place (CIP) systems, air handling units (AHU), reverse osmosis (RO), compressed gases, cooling water, and waste systems. Job Description/Skills: Generation of design specifications (URS, FS, DS) Draft and execute change control documents Execute FATs and SATs Proficient with reviewing and understanding construction drawings including PFDs, P&IDs, architectural, mechanical, and electrical drawings Draft SOPs for operation, maintenance, and calibration of equipment, utilities, and facilities Draft and execute commissioning test protocols Serve as the Engineering Subject Matter Expert (SME) during the planning, conceptual design, basic design, and detailed design phases of a project Support Failure Modes and Effects Analysis (FMEAs) on equipment and utility systems to identify and address high-risk failure modes to ensure adequate maintenance and reliability during operate and maintenance phase. Benefits/Perks: 401k Health Insurance Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?

Up to US$95 per hour

Los Angeles

Director of Clinical Operations

Director of Clinical Operations

Advanced Clinical Practitioner - Melbourne

Company Overview: A leading global Clinical Research Organisation (CRO) with a global presence is seeking a highly skilled and motivated Advanced Clinical Practitioner to join its dynamic team. Responsibilities: Clinical Assessment and Diagnosis: Conduct comprehensive assessments of patients, including history-taking, physical examinations, and diagnostic tests. Formulate accurate diagnoses and develop tailored treatment plans in collaboration with the healthcare team. Clinical Interventions and Treatments: Prescribe medications, treatments, and therapies based on established protocols and guidelines. Perform minor procedures and interventions within the scope of practice. Collaborative Care: Collaborate with physicians, nurses, therapists, and other healthcare professionals to coordinate patient care and ensure continuity of treatment. Provide expert consultation to colleagues on complex cases. Patient Education and Counseling: Educate patients and their families on health conditions, treatment options, and preventive measures. Offer counselling and support to promote patient well-being and adherence to treatment plans. Quality Assurance and Documentation: Maintain accurate and detailed medical records, including progress notes, treatment plans, and medication management. Ensure compliance with regulatory standards, clinical protocols, and best practices. Professional Development and Training: Engage in ongoing professional development activities, including attending workshops, conferences, and training sessions. Mentor and provide guidance to junior healthcare staff members. Requirements: Masters or above in nursing or equivalent qualifications; Active Nurse Practitioner Licensure Minimally five years of experience as a nurse practitioner/clinical nurse specialist within Haematology/Oncology; If you are highly motivated and dedicated, please apply with your CV attached.

Melbourne

Regulatory Submissions Manager - Melbourne

Company Overview: A leading global Clinical Research Organisation (CRO) with a global presence is seeking a highly skilled and motivated Regulatory Submissions Manager to join its dynamic team. Responsibilities: Regulatory Strategy: Develop and implement regulatory submission strategies for [products/therapeutic areas] in alignment with business goals and regulatory requirements. Submission Planning and Coordination: Plan, coordinate, and manage the preparation of regulatory submissions documents. Ensure submissions are complete, accurate, and comply with relevant regulatory guidelines and standards. Cross-functional Collaboration: Collaborate with cross-functional teams, including Regulatory Affairs, Clinical Development, Quality Assurance, and R&D, to gather necessary information for submissions. Provide guidance to project teams on regulatory submission requirements and timelines. Regulatory Documentation Management: Maintain and organize a repository of regulatory documents, ensuring version control, accessibility, and compliance with documentation standards. Quality Assurance and Compliance: Ensure that all regulatory submissions meet the highest quality standards and adhere to applicable regulatory requirements Health Authority Interactions: Facilitate interactions with regulatory agencies, including preparing and coordinating responses to agency inquiries and requests for additional information. Regulatory Intelligence: Stay abreast of evolving regulatory requirements, guidelines, and industry trends to provide strategic input on regulatory matters. Requirements: Bachelor's Degree in Science or a related field preferred. More than five years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience; If you are highly motivated and dedicated, please apply with your CV attached.

Melbourne

CRA - SG

Company Overview: A pioneering biopharmaceutical company dedicated to advancing healthcare through innovative therapeutic solutions. Founded on a commitment to bridge the gap in neurological research, The company focuses on discovering and developing novel treatments for a range of neurological disorders. Responsibilities: Site Management: Initiate, monitor, and close clinical trial sites to ensure compliance with study protocols, regulatory requirements, and company standards. Conduct site initiation visits to provide training on study procedures and protocols. Monitoring and Data Management: Perform routine monitoring visits to assess data accuracy, source document verification, and compliance with study protocols. Review and resolve data discrepancies and discrepancies between source documents and CRFs (Case Report Forms). Regulatory Compliance: Ensure that all study activities are conducted in accordance with applicable regulatory requirements, including ICH-GCP, FDA, and local regulatory authorities. Safety and Adverse Event Reporting: Monitor and report adverse events and serious adverse events in compliance with regulatory and company guidelines. Documentation and Reporting: Maintain accurate and up-to-date documentation, including site visit reports, monitoring logs, and study correspondence. Prepare and submit study progress reports to internal stakeholders and regulatory authorities. Collaboration and Communication: Foster effective communication and collaboration with investigators, site staff, and internal cross-functional teams. Participate in study team meetings and provide updates on-site activities. Requirements: Bachelor's Degree in Science or a related field preferred. Minimum of 2 years' CRA or related experience Good understanding of GCPs (Good Clinical Practices) Highly methodical and organized, including time-management skills and changing priorities Ability to manage multiple and varied tasks and prioritize workload with attention to detail Able to take initiative and work independently; a sense of urgency in completing tasks If you are a highly motivated and dedicated Clinical Research Associate, please apply with your CV attached.

Singapore