Senior Clinical Trial Manager Pulmonologie
01 june 2010Senior Clinical Project Manager Pulmonologie (0.8 - 1.0 Fte)
PROX is een staffing en consultancy bureau voor de Healthcare. Onze staffing is gericht op het matchen van kandidaten met opdrachtgevers binnen farmaceutische industrie, Medical Device Companies en op het vlak van Klinisch onderzoek. Door maatwerk te leveren, zowel aan de opdrachtgever als aan de werknemer, schept PROX een werkrelatie die gebaseerd is op kwaliteit, vertrouwen en integriteit.
De PROX filosofie is een way of working: informeel, initiatiefrijk en open minded. PROX-ers hebben de ruimte om hun persoonlijke leven en hun zakelijke carrière zo optimaal mogelijk te combineren zonder dat dit ten koste gaat van de kwaliteit van dienstverlening. PROX-ers bekennen kleur. Nemen stelling. Weten waar ze het over hebben en schromen niet de discussie te zoeken om het resultaat te verbeteren.
Ter versterking van ons team zijn wij op zoek naar een
Ervaren Clinical Trial Manager Pulmonologie (0.8 - 1.0 Fte)
JOB PURPOSE
Central point of communication between Sponsor and the Investigator for all clinical trial related activities to assure trials are conducted on time and budget, while fully GCP, ICH and Sponsor SOP compliant. Leads internal Sponsor teams to coordinate on the local CPO and/or the global level for a clinical trial, when assigned.
MAJOR ACCOUNTABILITY
- Nominate new sites for clinical trials; analyze capability and make recommendation for trial inclusion.
- Assume ambassadorial role to facilitate communication between sites and Sponsor line functions and increase value proposition to investigators.
- Facilitate preparation and collection of site level documents; resolve problems as required.
- Execute site selection and training.
- Assist in monitor activities when needed
- Implement total site management including monitoring visits, regulatory assessment, drug supply management and resolution of site problems to ensure compliance.
- Track trial execution milestones; monitor trial budget; identify problems; resolve issues and escalate as appropriate.
- Manage recruitment and execute contingency plans, as needed.
- Manage data at the site; resolve technical and content issues to achieve aggressive database lock targets.
- Act as local and/or global "Lead CRA" and author global monitoring plan.
- Act as a mentor to new associates for purposes of field training, as assigned.
- Participate in multi-disciplinary teams within CPO and globally to evaluate and implement process improvement.
DIMENSION
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Number of associates: |
Matrix: serves as local or global "Lead CRA" on trial level within CPO |
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Financial responsibility: (Budget, Cost, Sales, etc.) |
May be involved in budget negotiations and oversee trial budgets. |
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Impact on the organization: |
External impact: Sponsor perceived as a reliable and professional partner for executing clinical trials by customers and regulatory agencies. Internal impact: Direct impact on Sponsor decision making timelines and Health Authority submissions. |
KEY PERFORMANCE INDICATORS / MEASURES OF SUCCESS
- Delivery of patient recruitment and high quality data according to agreed timelines and budget, ensuring adherence to international and local regulations.
- Feedback of external (investigators) and internal (TA/ BU) customers.
IDEAL BACKGROUND
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Education (minimum/desirable): |
A degree in a scientific or health care discipline preferred. Relevant experience on exception only. |
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Languages: |
Fluent English (oral and written). |
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Experience/Professional requirement: |
1. Understand and apply medical and business knowledge to clinical trial execution. 2. At least 4 years experience in clinical research or having demonstrated adequate level of proficiency within the Trial Manager competency profile. 3. Solid understanding of clinical trial design, trial execution and operations. 4. Knowledge of international standards (GCP/ICH), international (FDA, EMEA) and local regulations. 5. Expertise in communication, managing multiple priorities and computer literacy. 6. Proven people management skills with demonstrated expertise in working on teams. |
Wil je meer weten over PROX of de vacature dan kan je contact opnemen met Marcel Hagmanns 033-4619088 of 06-50211039.Wij zien je CV met motivatie graag tegemoet.
E-mailadres: marcel@proxgroup.com