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- Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
- Responsible for project management of the assigned studies: pro-actively plans, drives, and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
- Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. Performs Quality control visits as required.
- 5-6 years of experience in clinical research, including Oncology trials, with experience as a CRA strongly preferred
- Bachelor in Science (or equivalent) required
- Advanced degree (e.g. Master. MD, PhD.) preferred
- up to 30% of working time
- Knowledge in Project Management, ability to make decisions independently and strong organizational skills with demonstrated success.
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures, and functions.
- Fluent in written and spoken Finnish and English
- The position requires proven strong project management skills and/or project management certification or relevant training program.
- Ability to identify problems, conflicts, and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical.
- Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations.
Clinical Research Manager - Espoo, Suomi - MSD
Kuvaus
Job Description
Clinical Research Manager (CRM) for Our Company in Finland
About the position
We are excited to be expanding our Clinical Trials Team in Finland. We are currently looking for highly motivated Clinical Research Manager (CRM) in Finland, who share our passion for getting safe and efficient treatment to patients.
As a CRM your role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country. We work cross border in our Nordic Baltic cluster and for certain studies you will be responsible for several countries in a cluster.
You will be leading very engaged study teams ensuring excellent study performance. Clinical Research at Our Company is given top priority and is a cornerstone of the business. Your role is important for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies. You will support local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TAH and Regional Operations.
You will collaborate internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance and Global Medical Affairs to align on key issues/decisions across the trials. We support your development; you can lead and contribute to initiatives and projects adding value to the business and supporting our strategy.
Responsibilities include, but are not limited to:
Experience and Educational Required
Travel Expectations
About you
We are looking for a colleague, who is ambitious, have strong communication skills and know how to inspire and convince other people. You are also driven, decisive and have a high sense of responsibility. You are someone who wants to move forward, is critical and shows initiative. You will be given every opportunity to develop yourself, based on a personal growth trajectory with a view to further growth in the future.
Furthermore, we are looking for a colleague with:
About us
As a workplace, Our Company offers an environment with a high degree of trust and opportunities to grow. We firmly believe in the ability to work as a team, and we pride ourselves in our prioritization of talent. We are a certified Great Place to Work, the social and professional well-being of our employees and colleagues are of the utmost importance.
We aspire to be the premier research-intensive biopharmaceutical company in the world. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs, and partnerships.
Today, we continue to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, cardiometabolic diseases, infectious diseases, Alzheimer's disease, and infectious diseases including HIV and Ebola. Our purpose is to save and improve lives for generations.
Our strategy is simple: We follow the science. The path to discovery is often unclear, but we are tireless in seeking solutions for some of the world's most difficult health challenges.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
08/17/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:08/17/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R305587