Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Senior Clinical Study Start Up Specialist
Eingestellt von Apex International
Gesuchte Skills: Marketing, Client
Projektbeschreibung
Job Title: Senior Clinical Study Start Up Specialist
Location: Buckinghamshire
Duration: 12 month contract
The Client: Pharma company with exciting portfolio
Benefits: Competitive Salary and benefits available - Full details available on application
The Role:
Develops, evaluates, and executes all essential clinical trial documents and clinical trial agreements (CTAs). Aligns execution activities with agreed upon project priorities, timings and quality specifications. Adheres to all relevant regulations including ICH and PhRMA guidelines and company SOPs and policies.
The contractor must conduct their work activities in compliance with all company internal requirements and with all applicable regulatory requirements. Company internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives as appropriate to the contract role.
The contractor will have strong computer skills, good organizational skills, ability to prioritize and a good understanding of clinical study costs.
The contractor is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. As a result the percentage of time spent across both roles for which the contractor is responsible for, or assisting with, will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
Working on getting the sites ready for the trials to start - so getting the sites up and running through having the necessary documentation (green light package) signed and sealed so that the study teams can then start recruiting patients, etc.
They work with an outsourced group who are the local specialists (based in country) who our team need to "manage" to ensure the project is progressing according to timelines.
We would ideally like someone with enough experience to include European start up experience.
Site Contracts - we would like someone else who has a good background in this if possible so that they can work extensively on the contracts.
There will potentially be an opportunity to work on EC submissions also but we are keen on someone with a background in Clinical Trial Agreement negotiation and execution.
Full details available on application
The Candidate:
A Bachelor's degree, preferably in a science or health-related discipline.
Previous experience of working in a clinical / regulatory contracts and negotiations role is preferred.
Cross Functional Relationships
Communication Skills
Decision Making
Execution/Results/Process Improvement
Customer Satisfaction
Application Details:
If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.
Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process.
About Apex: Apex International are an honest, knowledgeable and niche agency who recruit for the pharmaceutical, biotech and CRO sectors in the UK and EU. We specialise in the areas of: Medical Information, Medical Affairs, Pharmacovigilance, Drug Safety, Regulatory Affairs, Clinical Research, QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers). For a confidential and professional chat about your job requirements with an agency who are expert in the fields they recruit for, and for the chance to register for free and receive weekly job updates, please call on or email
Apex International hold Investors in People status and are a corporate member of the Recruitment and Employment Confederation (REC).
Recommend a Friend Reward!!!! If you refer someone who is not currently registered with us and we find them a new position, Apex will repay you with a £200 voucher bonus (of your choice!)
Our Passion - Your Profession - A consultative approach to recruitment.
We match professional candidates to the best permanent, contract and interim roles in the market
Website:
Keywords: Senior Clinical Syudy Start Up Specialist, RDCM, Clinical Trial Agreement, Site Contracts,Clinical Trial Agreement, Study ICF, Clinical Study Registration Document, CTMS, ICH, PhRMA, CFR, SOP's, Senior Clinical Syudy Start Up Specialist, RDCM, Clinical Trial Agreement, Site Contracts,Clinical Trial Agreement, Study ICF, Clinical Study Registration Document, CTMS, ICH, PhRMA, CFR, SOP's, Senior Clinical Syudy Start Up Specialist, RDCM, Clinical Trial Agreement, Site Contracts,Clinical Trial Agreement, Study ICF, Clinical Study Registration Document, CTMS, ICH, PhRMA, CFR, SOP's
Location: Buckinghamshire
Duration: 12 month contract
The Client: Pharma company with exciting portfolio
Benefits: Competitive Salary and benefits available - Full details available on application
The Role:
Develops, evaluates, and executes all essential clinical trial documents and clinical trial agreements (CTAs). Aligns execution activities with agreed upon project priorities, timings and quality specifications. Adheres to all relevant regulations including ICH and PhRMA guidelines and company SOPs and policies.
The contractor must conduct their work activities in compliance with all company internal requirements and with all applicable regulatory requirements. Company internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives as appropriate to the contract role.
The contractor will have strong computer skills, good organizational skills, ability to prioritize and a good understanding of clinical study costs.
The contractor is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. As a result the percentage of time spent across both roles for which the contractor is responsible for, or assisting with, will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
Working on getting the sites ready for the trials to start - so getting the sites up and running through having the necessary documentation (green light package) signed and sealed so that the study teams can then start recruiting patients, etc.
They work with an outsourced group who are the local specialists (based in country) who our team need to "manage" to ensure the project is progressing according to timelines.
We would ideally like someone with enough experience to include European start up experience.
Site Contracts - we would like someone else who has a good background in this if possible so that they can work extensively on the contracts.
There will potentially be an opportunity to work on EC submissions also but we are keen on someone with a background in Clinical Trial Agreement negotiation and execution.
Full details available on application
The Candidate:
A Bachelor's degree, preferably in a science or health-related discipline.
Previous experience of working in a clinical / regulatory contracts and negotiations role is preferred.
Cross Functional Relationships
Communication Skills
Decision Making
Execution/Results/Process Improvement
Customer Satisfaction
Application Details:
If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.
Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process.
About Apex: Apex International are an honest, knowledgeable and niche agency who recruit for the pharmaceutical, biotech and CRO sectors in the UK and EU. We specialise in the areas of: Medical Information, Medical Affairs, Pharmacovigilance, Drug Safety, Regulatory Affairs, Clinical Research, QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers). For a confidential and professional chat about your job requirements with an agency who are expert in the fields they recruit for, and for the chance to register for free and receive weekly job updates, please call on or email
Apex International hold Investors in People status and are a corporate member of the Recruitment and Employment Confederation (REC).
Recommend a Friend Reward!!!! If you refer someone who is not currently registered with us and we find them a new position, Apex will repay you with a £200 voucher bonus (of your choice!)
Our Passion - Your Profession - A consultative approach to recruitment.
We match professional candidates to the best permanent, contract and interim roles in the market
Website:
Keywords: Senior Clinical Syudy Start Up Specialist, RDCM, Clinical Trial Agreement, Site Contracts,Clinical Trial Agreement, Study ICF, Clinical Study Registration Document, CTMS, ICH, PhRMA, CFR, SOP's, Senior Clinical Syudy Start Up Specialist, RDCM, Clinical Trial Agreement, Site Contracts,Clinical Trial Agreement, Study ICF, Clinical Study Registration Document, CTMS, ICH, PhRMA, CFR, SOP's, Senior Clinical Syudy Start Up Specialist, RDCM, Clinical Trial Agreement, Site Contracts,Clinical Trial Agreement, Study ICF, Clinical Study Registration Document, CTMS, ICH, PhRMA, CFR, SOP's
Projektdetails
-
Einsatzort:
Bedfordshire, Vereinigtes Königreich
-
Projektbeginn:
asap
-
Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Marketing/Vertrieb