Closing Date: 27 May 17
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below
Clinical Research Manager Antwerp Area, Belgium Start date: 15/05/2017 TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Clinical Research Manager (Clinical Pharmacology & Pharmacometrics Project Lead) to strengthen the team of one of our clients (one of Top 10 Pharmaceutical Company). The Clinical Pharmacology & Pharmacometrics (CPPM) Therapeutic Area Project...
Clinical Research Manager
Antwerp Area, Belgium
Start date: 15/05/2017
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Clinical Research Manager (Clinical Pharmacology & Pharmacometrics Project Lead) to strengthen the team of one of our clients (one of Top 10 Pharmaceutical Company).
The Clinical Pharmacology & Pharmacometrics (CPPM) Therapeutic Area Project Lead role is responsible for seamless fully integrated E2E support at various levels for CPPM Programs (portfolio, study, program, submission level) in alignment with compound development strategy.
- Providing oversight to all outsourced CPPM deliverables and ensures that all activities (in-house/outsourced) of CPPM are in compliance with CPPM strategy, regulatory and legal requirements and with company SOPs;
- Serve as a go to person for outsourcing within CPPM and contributes to the implementing and execution of the sourcing strategy;
- Work closely together with CPPM leaders, CPPM scientists and Pharmacometrics Leaders (PMLs) within CPPM;
- Leads business process improvement initiatives to contribute to the efficiency and effectiveness of the CPPM organization.
- Assist CPPM Therapeuthic Area (TA) Group leaders and Pharmacometrics Group Leaders with portfolio management meetings to plan and manage the portfolio from a resource, planning and budget perspective in alignment with Project Management Office (PMO) Lead and compound development strategy;
- Maintain functional planning systems and facilitate communications within CPPM and between/across functions, related to planning, submissions, cost estimation, outsourcing, quarterly FTE/OOPs review/validation for financial planning, by compound;
- Coordinate and track pre- and post- CPPM submission related activities/deliverables across all TAs for one or more products in late development and established products ensuring alignment with, and delivery on, the compound submission plan;
- Establish timelines to support compound development plans, consistent with overall business plan and CP strategy in collaboration with: Project Management Office personnel, finance,
Global Clinical Development Operations Organization (GCDO), CPPM Leader, Pharmacometrics Leaders and other business partners;
- Represent CPPM in cross-functional working groups per compound, and other non-trial-specific project-related meetings, to provide input regarding project or submission deliverables;
- Serve as the point person for all sourcing related activties within CPPM;
- Closely follow up on timely execution and finalization of contracts/work orders with External Service Provider (ESPs)/vendors, in partnership with Janssen R&D Procurement;
- Lead training initiatives for external service providers/vendors;
- Provide leadership and direction in developing, improving and implementing processes and tools to enhance the efficient implementation of outsourcing strategy;
- Provide External Service Provider (ESP) management;
- Collaborate with Bioresearch Quality & Compliance (BRQC) department in support of process audits related to sourcing and vendor audits;
- Participate in initiatives and working groups related to Outsourcing;
- Coordinate OOPs estimates for business planning;
- Drive and facilitate process development and improvement initiatives (with ESPs). Conduct lessons learned;
- Carry out functional responsibilities in accordance to applicable SOPs and Regulatory requirements;
- Participate in optimization/maintenance of planning systems and tools.
Experience / Knowledge:
- B.S., M.S., PharmD or equivalent with 4 years of industrial experience or CRO experience in areas of Drug Development;
- In-depth knowledge of contracting processes and systems, as well as compliance requirements for paying of vendors engaged in clinical research activities;
- Project management experience;
- Experience managing cross-functional teams;
- Experience working with off shore teams across global time zones;
- Experience working with External Service Providers (preferred);
- Working knowledge of functional planning systems, tools and OOPs algorithms (preferred);
- Knowledge of clinical pharmacology/pharmacokinetics concepts (preferred);
- Experience with SharePoint, Excel, ARIBA (preferred).
- Ability to communicate effectively, verbally and in writing, to individuals and groups at various levels in the organization;
- Understanding of scientific operations associated with clinical pharmacology, clinical drug development, and overall pharmaceutical R&D process;
Estimated travel of up to 5% travel will be required, both domestic and international.
If you have the experience needed for this position, please contact Kamila Jezowska-Hulas, Consultant, or apply directly at email@example.com
Our benefits when working via TalentSource Life Sciences in Belgium:
- Dedicated Line Manager
- Monthly meetings/calls with line manager
- Employee satisfaction survey - your feedback is important for continuous improvement
- Annual appraisals development planning
- Yearly team event
- New Year's diner
- Group- and Hospitalisation insurance
- Electronic meal vouchers
- Internet reimbursement
- Company mobile phone
- Car with fuel card
Why TalentSource Life Sciences/Cromsource
Cromsource is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all 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 clear tools to manage both internal and client processes with the same methodology.
Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.
As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.
To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.
Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.
Key words: Clinical Research Manager, CPPM, Pharmacology, Pharmacometrics, project management, contracting, compliance
Clinical Project Manager
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
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