Senior Associate, Investigator-led Studies (Bucks or Hampshire) UK
Roles & Responsibilities of the positionResponsibilities and key activities include but are not limited to • Track receipt of investigator-led/non-client sponsored concepts / proposals and EA requests and facilitate / administer ISS or EA process as central point of contact • Facilitate communication with Sponsor via collaboration with TA/Medical staff (e.g.: acknowledgement of receipt of proposal, provision of scienti?c comments on protocol for ISS or communication with requesting EA physician regarding next steps following request approval) • Complete sponsor quali?cation process (in collaboration with TA /Medical staff as needed) • Facilitate categorization, review and approval of proposals with medical personnel (including documentation) • Initiate and ensure execution of Con?dential Disclosure Agreement where necessary • Facilitate team review process sign off for proposals, protocols and amendments and submit for review by Regional Medical TA Head, GDL or review committee • Support meetings internally and with Sponsor as appropriate (creating agendas, minutes, etc.) • Provide protocol submission package (or open case package for EA) including product speci?c safety information, details of ISS (or EA) process and requirements to sponsor for protocol review and start-up activities • Partner with Global / Regional Operations representative regarding drug forecasting including clinical trial labeling activities, expiry dates / memos Etc.Job RequirementsWhat is required • Excellent IT skills and ability to work fast and accurately across complex systems • Valid and current UK working eligibility • BA / BS/ BSc in the sciences or RN • General biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company Knowledge • Ability to understand technical, scienti?c and medical information • Understanding of drug development process • Familiar with concepts of clinical research • Advanced computer skills • Experience in interactions with outside vendors, e.g., CROs and contract labs • Experience with administration of site budgets and grants with supervision • Experience with development of prospective site-selection criteria • Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements • Ability to write and present clearly using scienti?c and clinical issues terminology • Experience dealing with time demands, incomplete information or unexpected events • Good organizational and planning skills • Experience working effectively in a team / matrix environmentRemuneration & other details• Permanent contract of employment with DOCS seconded to the client • Full-time • Office-based in the UK in Marlow (Bucks). Possibility of working fully home-based depending on client’s requirements. • Salary will depend on actual level of experience and skills • UK benefits to include 23 days annual leave, pension, healthcare cover, etc. Why Join DOCS? Work with the best! This is a great opportunity to further develop your career. To express your interest please send your CV today to find out more details to Elisabeth.Knighton@docsglobal.com or ring +33 964 25 67 65. *Applicants who have not had a response within two weeks should assume their application has been unsuccessful.