Clinical Operations Manager
vor 2 Monaten
Contract Type: Permanent
Closing date:
Reference: VN1761
- Who we are
Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems.
We are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and wellbeing.
What we will deliver
We focus on the development of a proprietary pipeline of wellness and healthcare products, with a specific focus on highly differentiated products that address unmet medical and consumer needs.
By leveraging our unique and enabling R&D capabilities, we are building a pipeline that includes inhalable medicines, nicotine replacement therapies (NRT), and consumer wellness products.
About the role:
As a Global Clinical Operations Manager, you will be required to drive and be involved hands-on when necessary in the setup and execution of the clinical trials. Success will, in part, be defined by efficient execution, high quality and timely deliverables of all associated aspects of the clinical trials, in compliance with company’s SOPs, Good Clinical Practice guidelines and any other relevant regulation.
Core responsibilities:
Responsible for trial management to ensure all aspects of trials phase I-IV are executed as planned, within timelines and budget:
- Own the quality, timelines, execution and deliverables of the allocated clinical trials
- Manage and coordinate the internal and external vendors involved in the clinical trial set up, including but not limited to: CRO, analytical labs, CMC, etc
- Participate in review of site contracts and budget negotiations with external parties (e.g CRO, bioanalytical lab, etc)
- Establish the Sponsor Trial Master File (including essential and non-essential document collection from CRO and other related parties) in a timely manner and ensure ongoing maintenance, close out, and regular quality control of the TMFs, including managing the reconciliation process, in compliance with company’s SOPs and GCP.
- Provide assistance with internal and external meetings.
- Organize study team internal meetings, including meeting minutes.
- Data Quality and Compliance
- Responsible for creating, disseminating, and evaluating metrics reports (i.e. enrollment, outstanding query and data reports, site startup status, etc.)
- Identify and escalate potential risks to Line Manager
- Establish relationship with study site personnel specifically, a study nurse to keep track of patient enrollment and treatment schedules. Ensure patient follow-ups for clinical results are received in timely manner
- Facilitate the distribution and tracking of trial supplies; maintain investigational product accountability and traceability, as needed
- Reporting status of the trial to senior management
- Ensure the conduct of the study is in compliance with the currently approved protocol/amendment(s), with current GCP guidelines and with applicable regulatory requirements.
- Perform other duties as assigned to ensure successful management and completion of clinical trial
Role Requirements:
- Minimum 5 years direct experience in planning and hands on managing all phases of clinical trials
- Skilled knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start-ups.
- Experience in CRO management
- Experience in managing IMP supplies management at the global level (vendors providing background meds, the standard of care medications, etc.)
- Experience with global trial budgets including development, negotiation, and completion of Clinical Trial Research Agreements
- Excellent oral and written communication, organizational and planning skills; maintains proper communications with other departments to ensure communication and good relationships in connection with matters related to clinical trial projects
- Detail-oriented, hands-on mentality and comfortable with broad responsibilities in an entrepreneurial, fast-paced, rapidly growing complex company environment.
- Travel to sites when necessary
Why Join Us?
We are bound by our shared passion for making a positive impact on the lives of patients and consumers. Vectura Fertin Pharma is a place where you can help shape the future of healthcare, where we collaborate, support, and inspire each other to achieve the best outcomes. As a growing business, we can offer a wealth of opportunity to develop your career both locally and in international settings.
We embrace hybrid and flexible working and are centered on delivering a ‘purpose-driven’ experience for all our employees.
Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of th
-
Head of Clinical Operations
vor 1 Monat
Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH VollzeitJob Title: Head of Clinical OperationsSixPeaks Bio, a biotechnology enterprise, is seeking an experienced Head of Clinical Operations to lead our clinical operations team. This role is crucial for the successful execution of our Phase I – III clinical trials and ensuring the highest standards of quality and compliance.Responsibilities:Lead and manage the...
-
Clinical Operations Director
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH VollzeitJob Title: Head of Clinical OperationsRidgeline Discovery GmbH is seeking an experienced and dynamic Head of Clinical Operations to lead our clinical operations team. This role is crucial for the successful execution of our Phase I – III clinical trials and ensuring the highest standards of quality and compliance.Key Responsibilities:Lead, mentor, and...
-
Clinical Operations Manager
vor 3 Monaten
Basel, Schweiz Indivi Vollzeit**Your mission**: Indivi is a medical technology company enabling precision medicine to become a reality in neuroscience research and development. The company is going through significant growth and looking for new team members to join and contribute to making the company vision a reality. **Your profile**: **Responsibilities and Requirements**: **Study...
-
Clinical Trials Manager
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Neurocrine Biosciences VollzeitAbout the RoleWe are seeking a highly skilled and experienced Clinical Trials Manager to join our team at Neurocrine Biosciences. As a key member of our clinical operations department, you will be responsible for managing the operational activities of clinical studies, from planning and initiation to conduct and close-out.Key ResponsibilitiesDevelop and lead...
-
Clinical Trials Manager
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Neurocrine Biosciences VollzeitAbout the RoleWe are seeking a highly skilled and experienced Clinical Trials Manager to join our team at Neurocrine Biosciences. As a key member of our clinical operations department, you will be responsible for managing the operational activities of clinical studies, from planning and initiation to conduct and close-out.Key ResponsibilitiesDevelop and lead...
-
Clinical Operations Coordinator
vor 2 Wochen
Basel, Basel-Stadt, Schweiz CK Group VollzeitClinical Operations Coordinator Job DescriptionAs a Clinical Operations Coordinator at CK Group, you will play a vital role in the operational management and oversight of clinical trials. Your main duties will include:Assisting the clinical operations team in the setup, conduct, and archiving of clinical trials.Coordinating the preparation and review of...
-
Clinical Operations Coordinator
vor 1 Monat
Basel, Basel-Stadt, Schweiz CK Group VollzeitClinical Operations CoordinatorWe are seeking a highly organized and detail-oriented Clinical Operations Coordinator to join our team at CK Group. As a Clinical Operations Coordinator, you will play a critical role in the operational management and oversight of clinical trials, ensuring seamless execution and compliance with regulatory requirements.Key...
-
Clinical Operations Coordinator
vor 1 Monat
Basel, Basel-Stadt, Schweiz CK Group VollzeitJob Title:Clinical Operations CoordinatorJob Summary:We are seeking a highly organized and detail-oriented Clinical Operations Coordinator to join our team at CK Group. As a Clinical Operations Coordinator, you will play a critical role in the operational management and oversight of clinical trials, ensuring seamless execution and compliance with regulatory...
-
Clinical Trials Manager
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Neurocrine Biosciences VollzeitAbout the RoleWe are seeking a highly skilled and experienced Clinical Trials Manager to join our team at Neurocrine Biosciences. As a key member of our clinical operations department, you will be responsible for managing the operational activities of clinical studies, from planning and initiation to conduct and close-out.Key ResponsibilitiesDevelop and lead...
-
Clinical Operations Coordinator
vor 3 Wochen
Basel, Basel-Stadt, Schweiz CK Group VollzeitClinical Operations CoordinatorWe are seeking a highly skilled Clinical Operations Coordinator to join our team at CK Group. As a key member of our clinical operations team, you will play a crucial role in the successful management and oversight of clinical trials.Key Responsibilities:Assist the clinical operations team in the operational management and...
-
Clinical Trials Manager
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Neurocrine Biosciences VollzeitAbout the Role:We are seeking a highly skilled Clinical Trials Manager to join our team at Neurocrine Biosciences. As a key member of our clinical operations team, you will be responsible for managing the operational activities of clinical studies, from planning and initiation to conduct and close-out phases.Your Key Responsibilities:Develop, lead, and...
-
Head of Clinical Operations
vor 3 Monaten
Basel, Schweiz Ridgeline Discovery GmbH VollzeitSixPeaks Bio is a Versant Ventures and Astra Zeneca funded biotechnology enterprise focused on advancing a portfolio of antibody-based compounds targeting obesity and associated co-morbidities. The company is a preclinical stage company with a pipeline of mAbs as well as mAb-peptide conjugates entering IND preparing studies in the next few months. Our team...
-
Clinical Operations Coordinator
vor 1 Monat
Basel, Schweiz CK Group VollzeitJob Title: Clinical Operations Coordinator Work Location: Allschwil, Basel Country: Switzerland Duration: 12 months Rate: Up to CHF56.77phr (8 Hours per day)Your main duties as an Clinical Operations Coordinator will include:Assists the clinical operations team in the operational management and oversight of clinical trials, during set-up, conduct and until...
-
Freelance Clinical Operations Manager
vor 5 Monaten
Basel, Schweiz AL Solutions VollzeitLiam Newton has partnered with a mid-large size Pharma who specialise within rare diseases. They are searching for an experienced Clinical Operations Manager, based in Basel. It is a 12 months contract with possibility of extension. It is mainly on site, based in Basel where you would be a part of a fantastic team where you would closely collaborate with...
-
Clinical Operations Coordinator
vor 3 Wochen
Basel, Basel-Stadt, Schweiz CK Group VollzeitClinical Operations CoordinatorJob Title: Clinical Operations CoordinatorWork Location: Allschwil, BaselCountry: SwitzerlandDuration: 12 monthsRate: Up to CHF56.77phr (8 Hours per day)Main Responsibilities:Assist the clinical operations team in the operational management and oversight of clinical trials, during set-up, conduct and until archiving, for an...
-
Clinical Trials Operations Manager
vor 1 Monat
Basel, Basel-Stadt, Schweiz Roche VollzeitAbout the RoleWe are seeking a highly skilled professional to join our Digital Biomarker team at Roche. As a Digital Biomarker Integration Specialist, you will play a critical role in the seamless integration of mobile sensor data workflows in the clinical development processes for our customers.Key ResponsibilitiesDevelop and execute our digital biomarker...
-
Head of Clinical Operations and Strategy
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH VollzeitAbout the RoleRidgeline Discovery GmbH is seeking an experienced and dynamic Head of Clinical Operations to lead our clinical operations team. This role is crucial for the successful execution of our Phase I – III clinical trials and ensuring the highest standards of quality and compliance.Key ResponsibilitiesLeadership and Management:Lead, mentor, manage,...
-
Head of Clinical Operations and Strategy
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH VollzeitAbout the RoleRidgeline Discovery GmbH is seeking an experienced and dynamic Head of Clinical Operations and Strategy to lead our clinical operations team. This role is crucial for the successful execution of our Phase I – III clinical trials and ensuring the highest standards of quality and compliance.Key ResponsibilitiesLeadership and Management:Lead,...
-
Sr. Clinical Trials Manager
vor 4 Wochen
Basel, Schweiz Neurocrine Bioscience VollzeitWho We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options. What We Do: Neurocrine...
-
Clinical Operations Coordinator
vor 1 Monat
Basel-Stadt, Schweiz CK Group VollzeitJob Title: Clinical Operations Coordinator Work Location: Allschwil, Basel Country: Switzerland Duration: 12 months Rate: Up to CHF56.77phr (8 Hours per day)Your main duties as an Clinical Operations Coordinator will include:Assists the clinical operations team in the operational management and oversight of clinical trials, during set-up, conduct and until...
