Boudry, Neuchatel, Switzerland Job Category:
Clinical Operations Work Location:
Route de Perreux 1 2017 Organization:
Clinical Trials Employee Status:
Full-time Job Type:
As we approach a critical time in our quest to deliver medical innovation, we are seeking a forward-thinking and self-sufficient Clinical Trial Associate to join our Global Medical Affairs team here at Celgene.
Focussing on late-phase studies, you will work cross-functionally as to progress projects whilst also collaborating with the respective Study Manager - this will principally involve contributing to the operational execution of Medical Affairs Sponsored Trials (interventional and/or non-interventional) as to ensure that the trials are completed on time, within budget, and in compliance with applicable regulations, guidelines, SOPs and WPs (as well as providing high-quality data).
In return, you will be joining a dynamic environment, where you will play a crucial part in a Global team, whilst also building your knowledge / experience of innovative studies within a fast-moving biopharma organisation.
Depending on experience, this hire can be made as Senior Clinical Trial Associate - for that to happen, you would be able to demonstrate prior "industry" experience (from either a pharma/biotech organisation or from vendor-side / CRO), as well as prior case studies from similar roles and relevant examples from when you have worked in an international environment (with "global" exposure).
Please note: This is a 2-year 'Maximum Duration' full-time contract, based from our International HQ in Boudry (Neuchatel), Switzerland.
(Due to acute business needs, and because we require an immediate hire, preference will be given to those who are already based in the vicinity and have short/no notice periods)
- Support the Study Team to select potential investigators and assess their interest in the study
- Participate in vendor management/oversight activities
- Participate in monitoring report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans
- Process drug shipments after gathering necessary essential documents and track the receipt of shipments if required. Reconcile IP at study level. (for interventional studies)
- Contribute to development / coordination of study training for study team, investigational sites, and vendors
- Contribute to the oversight of the required country regulatory and country/site IEC approvals/notifications
- Support Health Authority inspections and CQA audits as required
- Ensure full compliance (completeness & accuracy) of the required data in study management tools including CTMS, patient enrollment forecasting, etc.
- Manage TMF set-up, ongoing quality review, and final reconciliation
- Assist with the collection of various study documents such as country/site insurance, CSR appendices
- Have a significant role in managing the study documentation including:
- Distribute and, at times, create study documents for the study sites such as confidentiality agreements (CDA), feasibility questionnaires, study binders, etc.
- Maintain and track documents such as Investigator Brochures (IBs), insurance policies, documents that are expiring and IND safety letters
- Collect, quality review and submit documents to the Trial Master File (TMF)
- Perform quality control of the TMF as appropriate
- Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with Contract Research Organizations (CROs) and other vendors
- Generate, finalize and distribute study team agendas and meeting minutes Financial Management
Added Responsibilities (depending on Experience)
- Process and track payments to vendors and study sites as appropriate
- Assist with maintenance of study budget tracking tools as required
Education and Experience
- Moderate functional impact on the study team
- Manages multiple assignments with supervision
- Participates in service provider oversight
- Provides updates for functional area
- Builds relationships to achieve influence with others
About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
- You will possess at least a Bachelor's degree, within a Life Sciences field - it is advantageous to possess a MSc but not essential
- You will be able to demonstrate experience from within a pharmaceutical / Clinical Research Organisation domain
- As someone who is adept at working within a matrix environment, you will have proven communication skills and an ability to work independently
- You will have a positive mindset, embrace challenges, and also be able to trust the actions / advice of others
- It would be advantageous for you to have working knowledge of ICH / GCP guidelines
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.