Location: Belgium, Braine l'Alleud
Schedule: Permanent - Full time - Office/Home Based
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….
TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Senior Clinical Project Manager (SrCPM) to join our client-based team at one of the leading global biopharmaceutical companies. Our client is a world leader, mainly working in the fields of neurology and immunology. Working with both scientists and academics across the globe, they have a focus on new products and a strong science based approach.
CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
Scope of the role:
- Accountable for the delivery of one or more studies from protocol through to study report and archiving. These can be all types of study from First in Human to Phase IV
- Accountable for managing the interface between the client, Phase 1 Units, CROs and other vendors to ensure assigned studies are delivered according to contract specifications, with high quality, on time and on budget
- Accountable for leading the internal and Joint Clinical Study team; lead study specific decision-making, develop strategies for increasing study efficiencies and co-ordinate issue detection, resolution and, where necessary, escalation to the Program Delivery Leads
- The level of CPM assigned to a project (either CPM or Senior CPM) will be dependent on study complexity and type (e.g. First in Human studies), scope, size and geography.
- Senior CPMs will be accountable for more complex studies and/or those with high visibility such as pivotal trials or challenging POC studies
Main Job Tasks and Responsibilities:
- Lead one or more multi-functional, Clinical Study Team(s) / Joint Clinical Study teams, tailoring the communication interface to ensure effective co-ordination and communication within and across the company and CRO/Phase 1 Unit teams
- If a Clinical Pharmacology study, ensure selection of the optimal Phase I Unit within or outside the SPI framework depending on the specialist need of the study
- At the study kick-off meeting, articulate study scope, goals, and expectations of the client to the CRO/Phase 1 Unit and ensure any relevant information that may impact the set-up of the trial is highlighted and accounted for in the trial planning
- Creates, or contributes, to detailed planning of the study timelines, defining critical path, and enabling seamless, and timely, access to bioanalytical and/or safety data for review meetings and so allowing prompt decision making. Such as for Safety Monitoring/Data Monitoring Committees, planned Interim Analyses, and final data reporting for Results Interpretation Meetings and final CSR
- Ensure that the scope, and all tasks and responsibilities for a study, are appropriately reflected in all study contracts and amendments. Ensure that scope changes are tracked, appropriately endorsed, and reflected in contract amendments before implementation of activities by the CRO/Phase 1 Unit
- Review and challenge CRO/Phase 1 Unit strategy and plans, if appropriate
- Demonstrate robust oversight of sponsor delegated activities by regularly reviewing CRO/Phase 1 Unit performance through use of KPIs, metrics and deliverables, with a focus on trial subject safety, data quality, and critical activities that might delay the project or impact budget
- Ensure a risk assessment is performed and a Risk Mitigation Plan is set-up at the beginning of the study and maintained by the partner CRO
- Regularly monitor and assess the appropriateness of the risk mitigation plan with the Clinical Study Team(s) / Joint Clinical Study teams and ensure that the cause, impact, remedial actions & preventative steps are assessed for any issues identified to avoid recurrence. Findings, including mitigation plans, to be discussed with the CRO and communicated to all appropriate internal and external stakeholders
- Become familiar with the competitive landscape; engage with KOLs, investigational sites, patient advocacy groups and other relevant organizations
- Understand, manage, track and ensure accuracy of study budgets in systems, including the forecast and accrual information
- For assigned studies, work closely with the respective Program Delivery Leads, and other team members and stakeholders as required, to serve as the key internal clinical operations contact whilst keeping the PDL updated on all study issues
- Closely cooperate with OC&SP and, if applicable, relevant committees/governance bodies and/or CQA regarding the performance and quality of work received from the CROs/Phase 1 Units and other vendors
- Collaborate with members of Clinical Study Team(s) / Joint Clinical Study teams to develop clinical trial protocols, protocol amendments, and other relevant study documents by providing input and/or approval as defined in SOPs and, if applicable, Strategic Partnership (SP) documents. Ensure that these documents are appropriately updated, e.g. in case new safety information or other change in scope
- Work with CRO partners to define a study specific monitoring strategy. Review Monitoring Plans, and CRA generated reports (as appropriate)
- Provide input to aid in the development of the clinical database, and clinical operations focused review of the clinical database specifications during set-up, and support data cleaning and data evaluation meetings and Results Interpretation Meetings (RIMs)
- Support Data cleaning and data evaluation meetings (DEM) and Results Interpretation Meetings (RIMs)
- Support conduct of Data Monitoring Committee (DMC)/Safety Monitoring Committee (SMC) review meetings
- Ensure that Clinical Study Reports (CSRs) meet the objectives of the trial and correctly reflect the data and the study conduct, in collaboration with the study team members.
- Lead lessons learned meetings as appropriate for assigned studies with internal and CRO team members
- Ensure quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices
- Support any audit/inspection activities and support CQA to ensure that result findings from audits/inspections are appropriately addressed in a timely manner
- Asia Specific - support any Regulatory Authority consultation activities.sm
- Provide study specific training for internal (i.e. the client)and external (i.e. CRO, vendors, investigators) team members
- Identify issues/gaps in processes and interfaces with other groups and departments and contribute to developing recommendations for resolution. Contribute to process improvement initiatives, and share best practice experiences with line manager, peers and Partner CROs
- Visit investigational sites and Phase 1 Units to build and maintain relationships as well as to understand opportunities and challenges to study conduct, including enrollment, when needed for assigned clinical studies
- Travel including overnight stays- possibly global - required
- A Senior CPM is expected to mentor other colleagues, present clinical trial related information internally or to an external audience as appropriate
- A Senior CPM may be assigned to more complex studies and/or those with high visibility such as pivotal trials or challenging POC trials, or multiple studies running in parallel
- Perform other tasks as deemed necessary by the Company
Education and Experience:
- Bachelor's Degree
- At least three years' relevant experience in clinical development including team leadership
- Experience or capability to manage in-house and/or outsourced regional or global Phase 1, 2 or 3 studies (First in Human to multicenter clinical studies) from study start-up to study report completion
- A SrCPM must have substantial experience in study management in different indications and proven ability to manage complex multinational studies or multiple simultaneous studies from start to end
Specific Role Requirements and Skills:
- Clinical trial management in Early and Late Phase and team leadership
- Motivation, mentoring and integration of individuals on multi-functional international teams
- Delivery of scientific/medical presentations and training to both large and small audiences
- Excellent verbal and written communication in English
- Proficiency in the Microsoft office suite
- Good interpersonal skills
- Excellent time management and organizational skills
- Negotiation skills
- Scientific and technical knowledge:
- GCP and regulatory environment
- Medical knowledge and research expertise
- Basic principles of data management and statistics
- Proactive approach, drive and follow through
- Managing multiple concurrent responsibilities in an environment of changing priorities without close supervision
- Ability to handle detailed technical matters and team dynamics
- Reconciliation of conflicting priorities
Our Benefits in Belgium :
- Competitive Salary
- Group and hospitalisation insurance
- Electronic meal vouchers
- Internet reimbursement
- Company Car with fuel card depending on the function
- Dedicated Line Manager
- Regular face-to-face or phone meetings with line manager
- Full annual performance review process
- Ad-hoc team events and end of year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Key words: Clinical Project Manager, CPM, Senior Clinical Project Manager, SrCPM, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated
Clinical Project Manager, clinical trials, CRO, Pharmaceutical, Project Management, English