This position is within the Rare Diseases team, part of the Pharma Research and Early Development (pRED) organization. The position supports the overall planning, evaluation and documentation for assigned global Phases I-III studies in Rare Diseases, in close cooperation with other functions including Clinical Operations, reporting to the Translational Medicine Leader (TML).
Contribute to key study documents (protocols, ICFs, clinical study reports) and drive development of relevant data capture tools and perform periodic data review and data cleaning
Responsible for the preparation of the clinical science components of the study specific manuals
Support in the evaluation, interpretation and synthetic presentation of various scientific/ clinical data. Help in providing response to regulatory agency questions
Participate in study management as clinical science representative to ensure trial deliverables are met according to timelines, budget, quality standards and operational procedures, within a global multidisciplinary cross-functional Study Management Team (SMT)
Accompany operations personnel on site visits and provide training and science input to operation colleagues and study site staff, as agreed with clinical operations
Monitors study progress on a regular basis to identify any problems or issues that could affect the results or completion of the study; investigates and employs problem solving strategies.
Provide help in literature search, creation of dossiers on scientific and medical topics
Assists in the preparation of scientific abstracts, posters, and publications arising from studies in conjunction with clinical investigators.
You Are Analytical, Detail Orientated and a Good Communicator
Qualified with an advanced scientific degree (e.g. PhD, MS) in a relevant scientific field (e.g. Neuroscience,Pharmacology, Molecular Biology, Genetics).
Experienced in a clinical scientist role, preferably in a global position
Experienced in rare diseases / orphan drug development would be advantageous
Able to collaborate and work in a matrix environment and interact with a variety of individualsoutside (investigators, partners) and inside the company (e.g. regulatory affairs, biostatistics, clinicalpharmacology, CMC, project management)
Comfortable/experienced with data cleaning, data capture, monitoring and reporting tools
Strong communication and time-management skills to drive quality results
Familiar with ICH-GCP regulation and regulatory guidance documents about clinical trials
Fluent in English
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
