Hélécine, Walloon Region, Belgium
30+ years of experience in Clinical Operations commencing as CRA. Oversight, management and conduct of international phase II – III trials running in EU and US. Line management of Clinical Operations teams in Northern Europe (Benelux, France, Denmark). Strategic input, oversight and coordination of global trials program. Experience in following indications: pain (low back pain, osteoarthritis, diabetic neuropathy), atopic dermatitis, psoriasis, psoriatic arthritis, dermatomyositis, lupus, ulcerative colitis. * Strong Project Management skills * Define clear expectations and communication * Can manage cross functional teams * Coaching and mentoring junior staff * Management of external vendors * Solution-oriented * Quality and results driven * Analytical and scientific thinking * Excellent knowledge of ICH-GCP * Fluent in English, French, Dutch * MS office, MS project, e-tools
Provide strategic clinical operations expertise and input into the clinical development plan (CDP) and clinical development activities (support with competitive intelligence, site and patient intelligence, vendor selection and management, governance meetings). Ensure successful operational planning, execution and close out of above-mentioned strategies (Program timelines, budgets). Have overall clinical program level oversight (i.e. all studies with a compound or within a therapeutic area).