Senior Clinical Project Manager

3 weeks ago

Belfast, United Kingdom ARC Regulatory Full time

At ARC Regulatory, our experienced team is passionate about supporting the advancement of high-quality biomarker testing in precision medicine research. Our work on +40 precision medicine programmes across oncology, auto immune and cardiac therapy biomarkers, has helped deliver robust clinical data to expedite successful regulatory submissions and global market launches for pharma, laboratory and IVD clients, big and small.
ARC Regulatory continues to create a reputation as a "Great Place to Work". Our commitment centres around employee wellbeing. We enjoy a clearly defined company culture that puts team members, clients and patients, whose lives we seek to improve, at the centre of our day. ARC’s investment in career development means there is a career path available and each employee strengthens his/her knowledge of the complex regulatory environment for IVD and CDx medical devices.
Senior Clinical Project Manager (Devices and Diagnostics)
To be an integral member and significant contributor to project team(s) in the development and delivery of global compliance solutions to client companies, ensuring that client objectives are met and exceeded at all times. This will require the utilisation of a platinum standard approach to clinical research project management, internal and external stakeholder satisfaction as well as an innate work ethic that is aligned with the company’s core values.
Lead the work of the company and project teams in the provision of specialised clinical research assistance to client companies, ensuring expectations and interests are met.
· Contribute to the formulation and implementation of the short and medium-term Key Performance Indices/Indicators that allow for measurement of success.
· Research and prepare elements of clinical regulatory submission documents on behalf of client companies, including but not limited to CTA’s, Study risk determination requests, IDE submissions, IRB/REC Submissions.
· Contribute to the wider team’s in understanding the clinical operations requirements for an investigational device in the set-up, management & conduct of device clinical investigations worldwide.
· Prepare clinical affairs/operations quality management system audit reports and gap analyses on behalf of client companies.
· Contribute to the preparation of global clinical research guidance documents and white papers.
· Take advantage of professional networking opportunities in order to promote the company and its services to appropriate parties.
· Identify & undertake continuing professional development linked to personal objectives to ensure ongoing awareness of current quality and regulatory standards.
· Any other duties, within reason and capability, as determined by the Management
Engineering or Scientific degree at 2:2 honors or above
· MSc or PhD in science related subject
3+ years relevant medical device or IVD medical device industry experience or 5+ years relevant industry experience in life sciences or healthcare research
· Experience of risk management and CAPA systems
· Experience of developing quality management system documentation relevant to regulatory and/or clinical affairs
· Awareness of global regulatory submission requirements (e.g. EU/FDA/Health Canada)
· Awareness of regulatory requirements in emerging markets (e.g. Experience of clinical research regulatory requirements for companion diagnostics in the US or EU
· Experience of planning and conducting clinical performance evaluations for in vitro diagnostic medical devices
· Experience of generating and reviewing documents relevant to clinical studies: Strategy, Clinical Protocol, Monitoring Plans, Reports etc.
· Strategic planning for clinical studies including identification of and qualification of suitable clinical investigation sites
· Experienced in setting up global clinical investigation sites
Evidence of well-developed organisational, planning and time management abilities
· Proficient in the use of word processing, spreadsheet, database and presentation software
Valid full driving licence and vehicle insured for business use
· Able to travel as required, including European and possibly global travel
· Valid passport

  • Senior Clinical Project Manager

    3 weeks ago

    Belfast, United Kingdom HIRANI Full time

    Senior Clinical Project Manager (IVD/CDx) ARC Regulatory seeks applications from like-minded, culturally aligned and ethically strong clinical research professionals. Ideally, you have experience in in vitro diagnostic and/or companion in vitro diagnostic clinical study development, oversight, and management. Join the ARC team to be at the centre of...

  • Project Leader

    Found in: Talent UK C2 - 4 days ago

    Belfast, United Kingdom Pharmiweb Full time

    Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. We believe in our values, Patients First, Quality, Respect, Empowerment & Accountability. We are looking to recruit an experienced Project Leader...

  • Project Coordinator

    1 week ago

    Belfast, United Kingdom Association for Project Management Full time

    Project Delivery Support Coordinator Location: Custom House, Belfast - 3 days per week in the office, potential travel within Northern Ireland Contract Length: 12 months Pay Rate: GBP17 - GBP23 per hour PAYE/UMB A contract opportunity has become available with the Department for Agriculture, Environment and Rural Affairs of Northern Ireland for...

  • Clinical Operations Lead

    2 days ago

    Belfast, United Kingdom Alimentiv Full time

    Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison...

  • Mechanical Project Manager

    7 days ago

    Belfast, United Kingdom Association for Project Management Full time

    Your new company Hays are working in partnership with a well-established Mechanical Contractor known for their involvement in high-profile projects in the hospitality and commercial sectors. Given their robust lineup of projects for 2024/2025, they are seeking to recruit a Mechanical Project Manager to become a part of their team click apply for full job...

  • Technology Senior Project Manager

    3 weeks ago

    Belfast, United Kingdom Baker McKenzie Full time

    The Senior Project Manager - Technology PMO will be responsible for identifying and implementing best practices and developing methods and mechanisms to improve overall project delivery in terms of timelines, quality, and ultimately the stakeholder's satisfaction. Baker McKenzie is the world’s leading law firm with offices all over the world. Our Belfast...

  • Sailpoint Iiq Identity Management

    4 days ago

    Belfast, United Kingdom Project People Full time

    **SAILPOINT IIQ IDENTITY MANAGEMENT CONSULTANT- REMOTE - CONTRACT** We are hiring a **Sailpoint IIQ Identity Management Consultant** for one our clients in Belfast. **Required skills/experience** - Senior Level consultant with demonstrable experience of designing and deploying SailPoint Identity IIQ Identity Management solutions: - SailPoint Identity...

  • Electrical Project Manager

    3 weeks ago

    Belfast, United Kingdom Cibsejournal Full time

    One of the NI's leading M&E Contractors established over 50 years with a strong reputation for design, installation and commissioning of Electrical, Mechanical, Air Conditioning and Environmental services. Due to ongoing success and a strong order book including several multi-million pound projects, they are seeking to appoint a Senior Electrical Project...

  • Project Leader

    1 week ago

    Belfast, United Kingdom HIRANI Full time

    We are seeking to further strengthen the team by hiring a full-time, Project Leader to lead and manage one or several molecule projects (internal development and/or external strategic collaboration) within the company. The successful candidate will be a key member of the Belfast based team. Reporting to the Head of Biologics, he/she will work extensively...

  • Senior Director Clinical Operations

    3 weeks ago

    Belfast, United Kingdom Pharmiweb Full time

    Job Title: Head of Clinical Operations - Medical Device Company Overview: My client is a leading provider of innovative medical devices dedicated to improving patient outcomes and advancing healthcare globally. With a commitment to excellence and a passion for innovation, we are seeking a talented Head of Clinical Operations to join our dynamic team. ...

  • Senior Project Manager

    3 weeks ago

    Belfast, United Kingdom Baker McKenzie Full time

    The Senior Project Manager - Technology PMO will be responsible for identifying and implementing best practices and developing methods and mechanisms to improve overall project delivery in terms of timelines, quality, and ultimately the stakeholder's satisfaction. Baker McKenzie is the world’s leading law firm with offices all over the world. Our...

  • Senior Project Administrator

    1 week ago

    Belfast, United Kingdom Association for Project Management Full time

    Job Title: Project Administrator 86 per hour 5 hours per week - 3 days a week in the office The equip Programme is a large and complex regional transformation programme. It has been established on behalf of HSC to procure and implement replacements for the current Finance, Procurement, Logistics, Human Resources, Pay and Travel Management...

  • Senior Statistician

    3 weeks ago

    Belfast, United Kingdom Exploristics Ltd Full time

    SENIOR STATISTICIAN LEVEL 2 (REF. Contract: Permanent full-time/flexible working available (including part-time/compressed hours/term-time working) Location: Belfast office, home-based or hybrid working available Salary: £45k-£60k (based on experience) + attractive benefit package including 37 days holiday, private health insurance, company pension...

  • Clinical Pharmacist

    1 week ago

    Belfast, United Kingdom IQVIA LLC Full time

    Type : Full-time, hybrid (around 50% from home, 50% at GP surgeries) We are looking for pharmacists to join the team! Join us in this exciting role where you will utilise your clinical expertise and commercial acumen to support patients with chronic conditions in primary care settings. As a clinical pharmacist at Interface Clinical Services, an IQVIA...

  • Project Manager

    Found in: Jooble UK C2 - 3 weeks ago

    Belfast, United Kingdom Harland & Wolff Full time

    The successful jobholder will be responsible for the Cost Control /Project Controls function on our Fleet Solid Support (FSS Project)  Support the bid process utilising knowledge of Project Cost Controls, Work Breakdown Structure, reporting requirements etc.  Facilitate the inclusion of Production team for operational input into Bids. To develop an...

  • Project Manager

    3 weeks ago

    Belfast, United Kingdom Harland & Wolff Full time

    The successful jobholder will be responsible for the Cost Control /Project Controls function on our Fleet Solid Support (FSS Project)  Support the bid process utilising knowledge of Project Cost Controls, Work Breakdown Structure, reporting requirements etc.  Facilitate the inclusion of Production team for operational input into Bids. To develop an...

  • Project Manager

    1 week ago

    Belfast, United Kingdom communityni.org - Jobboard Full time

    The post holders will be part of the Action Renewables Project Management team. Responsibilities include carrying out work activities to support the Senior Project Managers within the Generator Admin and Consultancy teams. The post holders will have skills in report preparation, data & spreadsheet management, time management and an understanding of...

  • Project Manager

    3 days ago

    Belfast, United Kingdom Gregory Martin International Full time

    **Project Manager** **Engineering Project ManagerEssential Skills and Interests**: - Senior Technical Operations / Engineering management role within a manufacturing site or within a Consultancy. - Project management of significant engineering / continuous improvement projects / project portfolios. - Experience of reporting to and building rapport with...

  • Senior Manager, Project Management

    1 week ago

    Belfast, United Kingdom Turner & Townsend Full time

    That means delivering better outcomes for our clients, helping our people to realise their potential, and doing our part to create a prosperous society. Every day we help our major global clients deliver ambitious and highly technical projects, in over 130 countries worldwide. Our team is dynamic, innovative, and client-focused, supported by an inclusive...

  • Clinic Co-Ordinator

    Found in: Talent UK 2A C2 - 1 week ago

    Belfast, United Kingdom Savvi Recruitment Consultants Full time

    A pivotal role within the Clinic, as the Clinic Coordinator is the first person that our patients will interact with. Our team have a passion for patient care and building relationships with our patients. Our ideal candidate is someone who is likeminded and who wants to be part of our motivated team. The main responsibilities are efficient diary management,...