Senior Clinical Project Manager
at Any Venn Office/Homebased.
Venn Life Sciences is an Integrated Drug Development Partner offering a unique combination of drug development expertise and clinical trial design and management. This enables us to create, plan and execute drug and medical device development programs effectively and seamlessly for our clients. We have dedicated operations in Ireland, France, Germany, the Netherlands, the UK, the US, and Europe-wide representation.
Our mission is to deliver high quality drug and device development consulting and services to our customers across their full product development life cycle. We do this through developing our staff to be world class in their fields and forming real, lasting relationships with our clients.
We are currently looking for an experienced Senior Clinical Project Manager to join the Venn team. The position can be office or partially homebased, with 1 to 2 days per week in one of our offices. We are particularly interested in applicants from the Netherlands, UK, France or Germany.
The successful candidate will be responsible for the operational and financial performance of assigned project(s). They will coordinate and manage the activities of the clinical project, including managing costs, external vendors and the project team to agreed timelines adhering to SOPs, GCP and all appropriate legislation and guidelines.
If you are seeking a rewarding and challenging career this could be the perfect opportunity for you.
- Provide advice, expertise and leadership in the initiation, execution and completion of projects and maintain oversight of the end-to end activities, across contracted services.
- Serve as primary project contact with the Sponsor, providing advice on suitable project execution strategies and ensuring appropriate communication channels are maintained and reporting schedules adhered to.
- Develop and/or validate the clinical trial outline, project specific conventions (PSCs) and devise clinical trial documents (i.e. Project Management Plan).
- Provide overall trial strategy and regulatory advice on the submission process to the client. Act as client representative in communications with regulatory agencies.
- Prepare, review and/or validate clinical trial-related documents including but not limited to case report form, monitoring plan, data validation plan, data management plan, statistical analysis plan, pharmacovigilance documents, clinical trial report, regulatory documents, trial master file and electronic records, trial evaluation/lessons learnt materials, investigator brochures, trial abstracts, trial posters, trial manuscripts, as applicable.
- Acts as the primary project related representative of the project.
- Provide guidance and motivation to all team members involved in the conduct of the trial, ensuring trial tasks are conducted around common goals and established timelines.
- Recognise and solve problems and align with functional project stakeholders (e.g. QA, content expert, finance, management) to obtain advice and decision on priorities for implementation of solutions for good trial management.
- Ensure escalation and documentation of issues (e.g. quality, timeline, deliverables, budgets).
- Manage project budget to ensure that it is kept within agreed limits and perform regular reconciliation of finance/project reports, analysing and reporting status of budget, if applicable.
- Follow-up on changes in scope, timelines, budget and quality and report in good time to stakeholders.
- Ensure adherence to clinical trial protocol, GCP, SOP and Venn quality requirements (Venn Life Sciences or sponsor SOPs). Follow appropriate EMA and/or FDA guidelines and regulations, and applicable country specific guidelines.
- Provide operational advice including cost estimates for drug development plans with focus on early development up to clinical proof-of-concept.
- Contribute to business development e.g. identifying business opportunities, playing a supporting role in Requests for Proposals preparations etc.
- Ensure high level of customer satisfaction by focusing on efficiency and results and meeting customer expectations on assigned work activities.
Qualifications & Experience:
- Master’s or Bachelor’s (or comparable) level degree in life sciences, pharmacy, nursing or other relevant discipline.
- 5+ years’ relevant experience in clinical trials.
- 5+ year’s project management experience in a project management with experience leading complex and/or international projects.
- Strong budget/finance experience on a project level.
- Experience in coaching/mentoring other Project Manager’s.
- Up to date knowledge of the latest EMA/FDA relevant guidelines, and other relevant regulations.
- Experience in early drug development and a relevant working knowledge of clinical and regulatory requirements are of benefit.
- Team leader able to find effective solutions to deal with complex matters, exhibiting exemplary work and management ethics.
- Results and quality oriented with the ability to multi-task, with skill in establishing priorities, managing workload and meeting strict deadlines.
- Ability to anticipate potential issues and problems that may arise and proactively identify ways to resolve/mitigate.
- Ability to be flexible and to adapt and work effectively with a variety of situations or individuals.
- Team worker with excellent customer service and interpersonal skills, ability to communicate effectively and form positive relationships at all levels in and outside the company.
- Demonstrates excellent judgement and decision-making capability.
- Professional who is experienced and dependable with discretion, enthusiasm and a positive attitude.
- Proficiency in PC skills (e.g. SharePoint, Word, Excel, PowerPoint and Outlook).
- Excellent written and verbal communication skills including excellent command of English.
How to apply: Please forward your CV (in English) by email to Liane Brown-Feaheny, firstname.lastname@example.org
We do not require the services of agencies for this role.