Clinical Team Manager – Senior
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Clinical Trial Manager overseeing CRO clinical activities and Phase I study management for pharmaceutical development. Ensure compliance with GCP guidelines and timely delivery of clinical objectives.
Responsibilities:
- Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned Phase I clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely delivery and within budget, in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence.
- Ensure clinical activities coordination & oversight
- Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set-up (DM, reg, CMC, etc); ensure feasibility report are exhaustive.
- Review site feasibility reports as per oversight plan , support the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation, as per the oversight plan.
- Validate the final clinical study documents (such as study manual, monitoring plan, prepared by the Clinical CRO.
- Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organization and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate)
Requirements:
- Life science or medical graduate or other relevant qualifications.
- Minimum: CRA graduated
- Relevant experience of pharmaceutical drug development: Experience of minimum 1 year (ideally 2 years) of Lead CRA e.g. coordination of clinical activities/site management activities for the set up and running of international registrational studies (multiple sites/countries).
- Experience as a Field CRA monitor for at least 3 years (CROs or Pharma Industry)
- Experience in Phase I Oncology
- Excellent Knowledge of Good Clinical Practice (GCP), ICH regulations.
- Experience in preparing clinical study documentation for study set up, maintenance and closing
- Experience in managing and developing relationships with Contract Research Organizations (CROs).
- Global studies (multiple countries/sites) experience
- Previous experience in the Therapeutic area of studies (Neuroscience, Oncology or radiopharmaceutical compound, etc.) is a plus.
- English: Strong intermediate level
Benefits:
- Flexible work arrangements
- Professional development opportunities
Similar Jobs
Contracts Manager – Federal
Contracts Manager at Senture managing federal contracts, ensuring compliance with regulations, and leading contract negotiations. Requires US citizenship and 5+ years of contract management experience.
Consulting Manager, MedTech
Consulting Manager leading strategy consulting projects for MedTech clients. Overseeing teams and driving client engagement in the life sciences industry.
Service Delivery Manager – SMB
Service Delivery Manager overseeing B2B service deliveries for SMBs at T-Mobile. Ensuring high-quality outcomes through effective management and communication with internal teams.
Responsable des affaires réglementaires internationales CMC – produits pharmaceutiques
International Regulatory Affairs Manager for a leading pharma company working remotely in Canada, focusing on CMC regulatory affairs. Requires bilingual skills and technical knowledge of regulatory procedures.
Field Manager
Field Manager overseeing a team of technicians to achieve production goals. Responsible for managing operational expenses and providing guidance to technicians.
PMO Manager
PMO Manager leading program governance and project delivery discipline in a fast-growing technology firm. Ensuring initiatives align with strategic priorities and delivering clarity to all stakeholders.
Manager, Government Relations – Western Region
Manager, Government Relations leading engagement in the Western Region for Zillow Group. Building relationships with government leaders and executing regional strategies.
Manager, Government Relations
Manage Government Relations for Zillow, a leading real estate platform in the U.S. Drive initiatives while supporting customer needs and industry improvement.
Strategic Accounts Manager
Strategic Accounts Manager responsible for managing strategic customer relationships and driving revenue growth at Campspot. Collaborating with teams to enhance customer satisfaction and account performance.
Digital Solution Manager
Digital Solution Manager developing innovative solutions for customer needs. Working with interdisciplinary teams and utilizing AI technologies in a fully remote setting.
Senior Service Cost Optimization Manager
Senior Partner Account Manager ensuring cost savings while maintaining partner service quality for social discovery products. Analyzing performance metrics, developing cost reduction strategies, and managing partner relations.
Medicaid Systems Transition Manager
Medicaid Systems Transition Manager enhancing IT operations for government clients by managing Medicaid system upgrades. Collaborating with teams to ensure seamless service integration.
Consumer Engagement Manager
Consumer Engagement Manager creating and communicating incentive plans for sales teams. Engaging, coaching, and incentivizing to drive revenue for health insurance products.
Technical Manager
Techno-Functional Manager leading Data & AI delivery projects at Expleo. Ensuring agile project management and stakeholder coordination for successful execution.
Assistant Manager – Construction
Assistant Manager coordinating between employees and customers in the Elevator service industry, handling daily operations, safety audits, and client communication in Mumbai, India.
Prozessmanager
Prozessmanager at Dedalus improving healthcare processes for better care provision. Central role in clinical processes and stakeholder collaboration in a remote setting across Germany.
Process Manager
Prozessmanager managing clinical processes and stakeholder communication at Dedalus. Focusing on improving healthcare technology and operations for better patient care.
BI Claims Manager, Courier Delivery
Bodily Injury Manager at Reserv supporting claims director and overseeing delivery courier claims. Balancing leadership and individual responsibilities while promoting efficiency and team development.
APD Claims Manager, Courier Delivery
Claims Manager overseeing and providing support in commercial transportation and delivery claims at Reserv. Responsible for operational effectiveness and leveraging technology to drive efficiencies.
Integrations Manager, Contract
Integration Manager managing post-merger integrations for Podean, a global marketing agency. Overseeing integration planning and execution across cross-functional teams.