Clinical Development Consultant (CDC)

Région
Brussel
Publication
vendredi 3 août 2018
Date limite
lundi 3 septembre 2018
Réf
823BEXPE-BE
Contact
Sybille Ponet
Fonction
Autre
Niveau d'expérience
0 à 2 ans d'expérience
Type de contrat
CDI
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Clinical Development Consultant (CDC) Organisation description:

Our client was founded in 1876 by a man committed to creating high-quality medicines that met real needs in an era of unreliable elixirs peddled by questionable characters. His charge to the generations of employees who have followed was this: “Take what you find here and make it better and better.” More than 140 years later, they remain committed to his vision through every aspect of the business and the people they serve starting with those who take the medicines, and extending to health care professionals, employees and the communities in which we live.

Job description:

The Clinical Development Consultant (CDC) is responsible for providing operational expertise to customers through ownership of the site performance from site selection through site close out. The CDC is accountable for delivering investigator site commitments through their therapeutic area by identifying and selecting high performing investigator sites that regularly execute with high quality and cost-effective speed. The CDC is responsible for developing and managing institutional and key investigator relationships within a defined geography by serving as the primary interface between the company, the investigator, and the vendor representatives for a clinical trial. Main responsibilities: 1. Business Management: Site level accountability from Site Selection through Site Close out. Primary point of contact for institutions to identify and proactively resolve business process barriers. Partnering with other functional partners and vendors interacting with the sites and serving as the single point of accountability for the site (site selection, site activation, enrollment, data delivery, issue management, and closeout). Influence the development and implementation of site initiation/enrollment risk plans for clinical trials to ensure delivery on enrollment commitments. Own the issues management process at the site level, collaborating with Lilly partners, Quality, and other team members through both formal and informal interactions to resolve/escalate site specific issues when necessary. Oversee the delivery of data and clinical trial milestones at the site level. Leverage strategic knowledge of institution's decision making process along with historical performance with other Lilly clinical trials to deliver mutually acceptable business solutions. 2. Business Development: Identify, screen, evaluate and develop investigators for clinical trial participation. Influence the design of clinical study protocols including input to study manager on protocol and enrollment feasibility for studies to enable the successful enrollment and implementation of the clinical trial. Maintain technical expertise within a therapeutic area to engage in scientific discussions with the investigator and institution personnel. Develop and maintain relationships with therapeutic clinical trial sites. If applicable, negotiate budgets and contracts with institutions and investigators with an emphasis on usage of standard agreements and Fair Market Value (FMV). 3. Communication/Information Management: Serve as the primary sponsor point of contact for site personnel relative to clinical trial related issues. 4. Compliance: Oversee site level accountability for inspection readiness throughout the trial and in support of regulatory inspections. 5. External Influence: Influence and challenge internal and external environmental factors that impact clinical research strategy.

Profile:

Bachelor's degree or equivalent work experience in a scientific field or health-related field with no less than 3 years' experience in Clinical Trials/Development and good working knowledge of Good Clinical Practice. Experience in Oncology is an asset. Fluent in French, Dutch and excellent knowledge in English. Travel required within Belgium (50-60%)

Offer:

A permanent contract in an international lifescience environment and a Great place to work! Package including a company car and extra benefits.



Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713

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