Ablynx

Ablynx is a biopharmaceutical company engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx is dedicated to creating new medicines which will make a real difference to society. Today, the Company has approximately 40 proprietary and partnered programmes in development in various therapeutic areas including inflammation, haematology, immuno-oncology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Genzyme, Merck & Co., Inc., Merck KGaA, Novartis, Novo Nordisk and Taisho Pharmaceuticals. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.

 

Senior Early Development Operations Clinical Trial Manager

Job Summary:

The Senior Early Development Operations (EDO) Clinical Trial Manager (CTM) is responsible for the overall operational planning and activities for the implementation and conduct of clinical exploratory pharmacology / early development clinical trials in compliance with ICH, GCP’s, SOPs, local requirements, internal/departmental guidelines, and established timelines. The senior CTM is involved in the operational planning and scientific conduct of the clinical trial and acts as the leader of operational disciplines (Clinical Trial Team (CTT)) to guarantee release of homogeneous high quality clinical data in close collaboration with the EDO Data Manager (DM) and Clinical Study Director (CSD).

The senior CTM may manage studies at the product level (if applicable). The senior CTM may be involved in monitoring activities of his/her own studies according to workload/need and/or manages local monitoring or outsourced monitoring. The senior CTM may also participate in intra or inter-department Working Groups. The job may include international responsibilities.

Knowledge and skillsets:

  • Previous Phase I experience preferred
  • Knowledge of data management activities
  • Experience with management of outsourced activities
  • Previous and strong experience/expertise in medicine and medical terminology (including laboratory procedures/techniques and biological knowledge) and GCP/ICH guidelines
  • Very good understanding of R&D processes including the principals of study design and execution; knowledge of industry standards and practices.
  • Outstanding capability of interacting effectively with scientists and managers from various disciplines on an international basis
  • Expert and internal consultant on assigned area and liaise with external organizations on projects
  • Excellent interpersonal and communication skills (verbal and written)
  • Self-motivation, flexibility, attention to detail and organizational skills, goal-oriented
  • Expert in building optimal collaboration within the company and with external partners
  • Excellent ability to work in a team environment
  • Strong leadership abilities
  • Extensive project Management skills
  • Experience with various computer systems/database; a willingness to learn new systems/databases
  • Excellent ability to prioritize activities
  • Results-driven in terms of timelines and quality

Duties and responsibilities:

  • Provide management and oversight of clinical trials (which may include phase 1 studies and complex, multiple center and multinational proof-of-concept studies) to ensure progress according to study timelines
    • Lead the Clinical Trial Team (CTT) including representatives of all operational disciplines involved in the conduct of trial (i.e., CRAs/CROs, Data Management, Pharmacovigilance, Early Development Operations, Biostatistics, Pharmacokinetics, Clinical Supplies and other relevant departments, platforms or units).
    • Manage the study according to Good Clinical Practice(s) and local and/or national regulations, with responsibilities on product and project level.
    • Collaborate with team members on a day-to-day basis; in particular, build a strong collaboration with the Data Manager (DM) and the Clinical Study Director (CSD).
    • Anticipate bottlenecks in all steps of the study and development/implementation of counteractive measures
    • Solve or coordinate the resolution of issues during conduct of the trial
    • Develop and review specific study-related documents
    • Develop and coordinate the study budget, including invoice validation
    • Contribute to contract process
    • Manage investigational product supplies (ordering, packaging, and shipment)
    • Participate in and contribute to internal audits, if applicable
    • Serve as main contact for clinical sites and other outsourced activities
    • Manage local Monitoring Team when applicable
    • Manage outsourced centralized activities when applicable (Central Lab)
  • May perform studies following some Phase 2-3 processes when applicable (multicenter-multi-country Phase 2a trials)
  • Collect, synthesize, report, file and prepare archiving for clinical trial activities
  • Manage CRO/study sites
  • Manage outsourced/sub-contracted monitoring activities (including international monitors), when applicable
  • Conduct field (co-) monitoring activities, if required
  • Mentor and train/coach Associate CTMs, CTMs, apprentices or trainees
  • Lead/participate in department or participate in inter-department Working Groups, if applicable

Qualifications:

  • BAC +4/5 (Master's Degree)
  • 8/10 years minimum in clinical research, including a strong international background
  • Field monitoring experience or related experience is required.
  • Strong English communication skills (verbal and written) if English is a second language.
  • Successful prior management and/or supervisory experience in clinical operations are required.
  • Clinical Trials Management or Project Management experience required (approximately 5-8 years).
  • Recognized expertise in cross functional operations.
  • Preferably experience in Phase 1 clinical trials

 

Your application will be evaluated by the HR department of Ablynx itself. For any additional feedback regarding your application, we kindly refer you to the Ablynx HR department.


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