SEC Pharma is advertising an exciting opportunity for a Senior Project Manager (Clinical) to work on novel therapeutic agents of an exciting biotechnology company with pre-clinical and clinical assets in Immuno-therapy. This is a freelance role offered on a 12-month rolling contract, starting in December 2020.This role is rolled-out on a FSP model, whereby the Senior Project Manager (Clinical) will be working with the sponsor's clinical team and be accountable for ensuring that all project deliverables meet the customer's expectations - including timelines, budgets, resources, vendors, and key project deliverables in compliance with SOPs and regulatory requirements.Responsibilities: - Accountable for the overall management and delivery of clinical studies from start-up through close-out.- Work cross-functionally with other departments on a global-matrix environment to anticipate problems and provide resolution plans to ensure successful delivery.- Act as primary point-of-contact to the sponsor, an integrated team member with the mutual aim of driving project deliverables within time and budget.- Manage assigned budget.- Utilise a range of negotiation techniques to achieve commercial and organisational objectives.- Use clear and effective communication skills, with an ability to persuade and influence others.Education and experience:- Bachelor's degree or licensed certified health care training.- Experience managing clinical trials (phase I-III) in the Rare Diseases / Oncology field - HIGHLY DESIREABLE.- Established experience working within a CRO, as a Project Manager.- A proven track-record of successfully running clinical trials (min. 7 years) and in leading and developing professional staff in a project-led environment.- In depth understanding and experience with budgeting, forecasting and resource management- Adept user of project management software- A Valid PassportApply:1) To apply, please send your CV to Roy at roy.nelson@secpharma.com. 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 advertising an exciting opportunity for an experienced Freelance Senior Clinical Research Associate / CRA based in multiple locations across The United Kingdom and Ireland.Contract Overview:- Freelance Senior CRA- 6-12 months- FTE 1- Immediate start- No specific Therapeutic Experience required Main responsibilities (not limited to):- Acting as the main point of contact for all assigned sites, managing all site queries/issues and maintaining close site relationships.-Independently conducting site selection, site initiation, routine interim monitoring & close-out visits.- Completion of monitoring reports and follow-up letters; including all key findings and recommendations for future actions.- Maintaining Trial Master File (TMF)/electronic Trial Master File (eTMF).- Mentoring junior CRA'sExperience and Qualification Requirements (not limited to):- Minimum 8 years independent monitoring experience, covering SIV, S- Experience working on multiple protocols and excellent organisational skills.- BSc in a Life Science related discipline.- Valid UK Drivers Licence.To apply:1) Send your CV to Roy at roy.nelson(at)secpharma.com briefly outlining your therapeutic experience (study breakdown) 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 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 100% remote position, part-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.