SEC Pharma is advertising an exciting opportunity for an experienced Freelance Senior Clinical Project Manager based anywhere in the UK, on behalf of a growing, small-sized CRO offering full-service drug development management to start-up biotechnology organisations.The role of the Senior Clinical Project Manager will be primarily to lead and manage early phase oncology studies across globally, in a cross-functional role, driving study timelines from study set-up through to delivery.This is a fully-remote position, full-time, starting ASAP.Main responsibilities (not limited to):- Lead and manage multiple global early phase oncology studies to meet client specifications - Provide strong leadership of cross functional teams including key members of clinical study team (i.e. local CTM, CRA), data managers and more.- Provide strategic planning expertise, and ensure operational feasibility of clinical development plans.- Accountable for budget and timeline management.- Provide support to CRA teams with regards to protocol, therapeutic area and study procedures and SOP training Oversight of local teams to obtain ethics approvals and negotiating site contracts.Key Skills:- Excellent communication skills (verbal and written), organisation, presentation and time management skills.- Ability to review data and related procedures in detail- Capable to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.- Ability to oversee and manage CROs throughout the entire clinical operations life cycle of a study.Requirement:- Minimum BSc in the life sciences, nursing degree, or equivalent combination of education and experience.- Minimum 5 years of study management experience, along with a minimum of 8 years experience in clinical research.- CRO and pharma/biotech background.- Experience of conduct and management of multinational clinical trials.- CRA background is desirable.- Track-record clinical research experience gained within a contract research organisation (CRO), pharmaceutical, or biotechnology company.- In-depth knowledge of regulatory requirements, clinical development, and clinical monitoring procedures.- Proficient with ICH/GCP guidelines.Apply:1) To apply, please send your CV to Roy at roy.nelson@secpharma.com briefly outlining your study management experience and suitability for the role. For further information call +44 207 255 66 00.2) Click the Apply entry on this pageSEC Pharma is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, bio-pharmaceutical, biotechnology and medical device companies.

SEC Pharma is recruiting for a Senior Clinical Research Scientist on behalf of a globally renowned pharmaceutical company, with a scope to contribute to the development of early phase Haemato-Oncologic compounds from a clinical science perspectiveThe ideal candidate will constructively and collaboratively work with the clinical physician to establish the development strategies of early phase candidates, while actively liaising with the Global Clinical Project Manager and related study teamsAs part of an enormous stage of growth as a company, our pharmaceutical partner is seeking to engage with an experience professional on a freelancing-basis, so-to-say a consultant, on a long term guaranteeing a minimum of 18 months. The ideal candidate will be based ANYWHERE in continental Europe and WORK FROM HOME.Job Title: Senior Clinical Research Scientist Location: Anywhere in Europe (Continental)Home-based: YesFull time: 40 hours a weekContract length: min 18 monthsStart date: ASAPMain Responsibility:- To serve and represent the translation medicine to internal stakeholders cross-functionally- To contribute to the compilation and implementation of clinical development strategy from a clinical science point-of-view- To author, review and amend clinical study protocols, informed consent forms, case study reports and other clinical study-related documents, in collaboration with physician(s) and study management team- To oversee the preparation of clinical data review plans in collaboration with data managers and statistical programmers- To work closely with the clinical operations personnel, data managers, drug safety managers to review and reconcile clinical data promptly prior to extraction of data- To lead the compilation of abstracts, posters, manuscripts and preparations for peer-review purposes, which results are utilised also at various external meetings- To contribute in the preparations of agenda and meetings for advisory board and investigator meetings.- To attend professional meetings, congressesExperience and Education:- A Life Science-related degree. Advanced degree (MSN, MD, MS, PharmD or Phd) is an increased bonus- 7-10 years of relevant experience as a Clinical Development / Research Scientist within a biotechnology, pharmaceutical settings- Experience in Haematology / Oncology is a MUST- Experience in early development (phase I to proof-of-concept protocol development) is highly desirable- Experience compiling INDs / CTA and other regulatory submission documents- Experience in clinical study protocol, informed consent, case report form design and clinical study report writing - Basic knowledge of pharmacokinetics, and/or biomarker development/applications, clinical data.To apply for this position, please send your CV to Roy at roy.nelson@secpharma.com , outlining your interest and key experience within the email. To learn more about this opportunity, call +44 207 255 66 20 and reference " RN1145 FREELANCE Senior Clinical Research Scientist - Haemato-Oncology ".KEYWORDS:Phase 1, Translational Medicine, proof of concept, PoC, clinical science, pharmacokinetics, biomarker, oncology, cancer, oncologic, malignant haematology, malignant hematology, malignant haematologic, malignant hematologic, tumor, tumour, onco hematology, onco haematology, cancer biology, clinical, protocol, study, analysis data, informed consent, advisory board, case report form, study report, investigator meeting, data review, clincial development science, clinical development scientist, cross-fucntional clinical development, IND, CTA, study protocol, protocol amendment, clinical research scientist, clinical scientist, scientist, early phase science