Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Clinical Research Manager

Company: Clintec
Location:
Reference: EMEA-FTC-802
Closing Date: 17 Nov 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

The Clinical Research Manager (CRM) has a significant impact on how a country can deliver country-specific trial commitments and objectives. This position will build business relationships and represent our sponsor with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships. .

Requirements:

Clinical Research Manager - Russia, Moscow - Permanent  Contract - Office based Opportunity

Clintec is actively recruiting for a Clinical Research Manager to join our expanding global company. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

The Clinical Research Manager (CRM) has a significant impact on how a country can deliver country-specific trial commitments and objectives. As a customer-facing role, this position will build business relationships and represent our sponsor with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships.
The position requires the ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director.

Responsibilities
•The is CRM accountable for the 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.
•The CRM is the country point of contact (POC) for assigned protocols between ROC and CO and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles. The CRM forecasts country resource needs and serves local business needs (signs contracts, manages budgets as delegated).
•The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/or CTCs and training compliance. Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed.
•The CRM is responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners. The CRM oversees country and site validations, site selection and recruitment in assigned protocols.
•The CRM is responsible for clinical trial education to sites, and acts as the country POC for programmatically outsourced trials for assigned protocols. In collaboration with CRD, represents our sponsor in Pharma industry issues and in seeking influence in external R&D environment.
•The CRM collaborates internally with GMA/GHH, local PV and Regulatory Affairs to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. The position requires coordination and alignment with the regional and broader organization.
•The ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical. The position requires skilful negotiation in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing. 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 on country level.

Essential Criteria
•Bachelors Degree in Life Sciences, Medicine or Nursing or equivalent qualification / experience with CRA experience is highly preferred
•Knowledgeable about the drug development process, ICH-GCP and Local Regulatory Processes
•Expert in clinical trial monitoring with recent practical hands on experience and the proven ability to coach, mentor and motivate others in this discipline.
•Excellent communication skills including the ability to interact with clients and team members at all levels.
•Good presentation skills in keeping with Clintec corporate image.
•Ability to proactively identify issues and risks, and put in place mitigation and improvement measures where needed.
•Fluent in English and Russian languages

Company Information:
ClinTec International is a UK-based, dynamic privately owned full service Contract Research Organization with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries for over a decade and assist in their key product development efforts. At ClinTec International, we pride ourselves on delivering high quality, flexible and professional services/solutions for our clients. ClinTec International has a wealth of experience in managing clinical trials in all major therapeutic areas including oncology, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

ClinTec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects - with the opportunity to develop, progress and travel globally. ClinTec International offers a competitive salary and rewards package.

Apply for this job: Clinical Research Manager

Contact Information:

Address:  Head Office
Clintec International Ltd,
133 Finnieston Street,
Glasgow
G3 8HB
Scotland
Reasons to work for Clintec
Tel:  +44 (0) 141 226 1120
Fax:  +44 (0) 141 248 8993
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.