Senior Clinical Trial Coordinator
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POST DATE 3/21/2017
END DATE 5/23/2017
JOB DESCRIPTIONA career with us is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Who we are:
EMD Serono is the North American biopharma brand of Merck KGaA, Darmstadt, Germany - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the brand has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas.
To support Clinical Trial Leaders, Trial Teams and Clinical Operations Team in the planning, execution, management and surveillance of clinical trial/s. Conduct delegated task packages under own responsibility. Represent role model to other CTCs / colleagues or departments.
All tasks must be conducted in accordance with applicable Company Policies, Guidelines, Standard Operating Procedures (SOPs) and other Guidance and Standards, as well as current Good Clinical Practice (ICH-GCP) and applicable national regulations.
KEY TASKS & RESPONSIBILITIES
* Support CTLs/ Trial Teams/ COT for budget management under own responsibility, budget forecast as well as for building accruals as appropriate
* Knowledge and usage of databases and programs of the department
* Proficient in using and training other CTCs on the financial tools / systems to create accurate financial documents
* Responsible for invoice processing and tracking in a timely manner
* Ensure all financial documentation is audit ready for inspection at all times
* Support CTLs for surveillance of Merck / EMD Serono company compliance in trials/programs
* Review the Clinical Trial Management System for any relevant details required. Ensure in conjunction with the CTL that all systems are updated on a regular basis
* Perform TMF vendor surveillance as appropriate. Communicate with CRO or other functions accordingly to ensure TMF inspection readiness at all times
* Prepare and coordinate the process for the creation of legal documents for clinical trials/programs, e.g. Power of Attorney
* Ensure together with CTLs/ Trial Teams/ COT that risk management for the corresponding trials / programs is established and updated on an ongoing basis together with the CRO
* Contribute to workshops / special initiatives as expert/ professional for dedicated topics
* Prepare and hold presentations for training sessions, line managers meetings, department meetings, program or trial meetings as required
* Support CTLs/ Trial Teams/ COT in trial medication activities, if required
* Support CTLs/ Trial Teams/ COT with special activities for vendor surveillance.
* Develop and maintain complex administrative systems / reports and formats
* Ensure all trackers are maintained in an up to date manner and available for the CTLs/ Trial Teams/ COT to consult
* Support CTLs for Investigator Meetings, as applicable. Ensure correct code of practice / compliance is adhered to by the CRO and relevant information is provided to assist this process
* Organize meetings that are not under the responsibility of the CRO, as required
* Assist in the development of and/or delivery of presentations, as requested
* In conjunction with the CRO, establish and maintain archiving according to ICH-GCP, company SOPs and WIs, as requested
* Assist the CTLs/ Trial Teams/ COT in preparation of Audits or Inspections and participate in Audit and Inspection interviews, as required
* Drive/Coordinate the set-up and follow-up of Corrective and Preventive Action Plans (CAPAs) associated with Audits, as requested
* Demonstrate ownership for all assigned tasks and demonstrate a willingness to build knowledge
* Make process improvement suggestions and develop new process approaches
* Take on additional tasks as assigned by management
* Represent role model to CTCs and/or other departments or external partners
* Contribute to training and provision of direction and guidance to increase knowledge of new team members / new employees
* Ensure harmonization of processes throughout Global Clinical Operations
* Participate in indication- or program-specific trainings
Who you are:
* Experience in a clinical research-related position (four years or equivalent)
* Excellent computer skills including knowledge of MS Office(tm) (Excel(tm), Word(tm), PowerPoint(tm)) and Lotus Notes(tm). Database skills an advantage. Ability to work with multiple computer applications
* Excellent understanding of the policies and procedures of Clinical Operations and of ICH-GCP
* Advanced knowledge of medical terminology (and therapeutic areas)
* Good understanding of the responsibilities and needs of other functions in a clinical trial
* Experience working in a high volume environment while maintaining both organization and the ability to multitask
* Excellent administrative skills
* Experience in risk management and audit / inspection readiness preparation
* Ability to supervise, mentor and coach junior staff
* Communication skills including working processes in English as the main business language, proven experience in clinical trial management terminology
* Excellent time and priority management, ability to work efficiently under pressure
* Reliable, conscientious and confidential
* Highly motivated, shows initiative, is proactive and able to work independently as well as in a team
* Excellent communication skills - both verbal and written
* Strong interpersonal skills and ability to deal with people at all levels with sensitivity and tact
* Strong organizational and problem-solving skills
* Ability to provide advice and guidance to others and to direct, motivate people
* Willing to take on responsibility
* Ability to work in an international/ multicultural matrix environment
* Secondary education with commercial or secretarial diploma(s) (or local equivalent) or higher degree
* Science degree or biomedical degree an asset
* Very good oral and written communication in English
* Other languages an asset
What we offer:
Your possibilities to develop in our growing company are just as manifold as our product portfolio. We offer a modern and international working environment to unleash your innovative potential in diverse teams, and take responsibility for our employees, products, the environment and society.
Curious? Apply and find more information at come2emd.com
Equal Employment Opportunity
The Company is an Equal Employment Opportunity employer.
No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to