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Job Details

CRA Line Manager (home-based/UK)

Company: DOCS Global
Location: United Kingdom
Reference: Ref AS-022879
Closing Date: 22 Nov 17
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

Why Join DOCS? If you are an experienced clinical project manager professional looking for a new career opportunity, please send your CV today to Elisabeth.Knighton@docsglobal.com or ring +33 964 25 67 65. *Applicants who have not had a response within two weeks should assume their application has been unsuccessful.

Requirements:

Roles & Responsibilities of the position

SECTION 1: POSITION SUMMARY

• The role of the Line manager is to line manage CRAs and/or CTAs effectively, ensuring high performance, quality and continuous development. Including interviewing, evaluating and selecting CTAs and CRAs
• To assist the company in performing oversight in fulfilling its site management activities and obligations in relation to clinical studies as the primary sponsor of those studies.
• Create a culture of process improvement with a focus on streamlining processes adding value to our business and meeting the company’s needs
• Travel (approximately 50%) domestic and international
• In addition to work according to and comply with relevant company/client procedures and processes

SECTION 2: JOB FUNCTIONS/RESPONSIBILITIES

Line Management Activities:
• Act as point of contact for the client and DOCS
• Manage key activities as needed to cover CRA/CTA absence
• Perform CRA accompanied visits within 3 months of CRA on-boarding and routinely thereafter according to the Quality Oversight Plan
• Conduct activities detailed in the Quality Oversight Plan
• Interact with strategic partners (KOLs, Investigators and Site Staff) as necessary for execution of clinical trials and reinforcement of the client’s /company’s brand
• Ensure FSP staff achieve expected quality compliance standards with all appropriate SOPs, policies, regulations and guidelines, including spot check review of reports and spot co-monitoring with CRAs
• Support FSP staff to achieve delivery of study objectives
• Supports CRAs with resolution of significant site issues and development of recruitment strategies
• Ensures that CRAs and CTAs are qualified and trained, both in clinical studies execution and in the client’s policies and procedures, to provide data that meets quality requirements
• Provide leadership in the continuous improvement in CRA and CTA performance and monitoring processes
• Etc.

Job Requirements

SECTION 3: EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS

Knowledge:
• Clinical trial processes and operations
• ICH/GCP Guidelines plus local codes of practice as applicable

Experience:
• For CRA LM: experience as CRA with LM potential as determined by hiring manager, CRA manager, project manager or equivalent job role
• For CTA LM: as above or experience as CTA with LM potential as determined by hiring manager

Competencies:
• Attention to detail
• Organizational skills
• Relationship management & influencing skills
• Time management & prioritization
• Training skills
• Flexibility
• Written and oral communication skills
• Language skills: English
• Good working knowledge of common software packages
• Presentation skills
• Problem solver
• Team work

SECTION 4: EDUCATION REQUIREMENTS

Basic qualifications (meet 100%):
• BA/BS/BSc or qualified nurse (RN)
• Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)

Preferred qualifications:
• BA/BS/BSc in the life sciences or RN

Remuneration & other details

Permanent contract of employment;
Full-time;
Home-based
Market leading salary ranging depending on level of skills and experience, plus company benefits (25 days annual leave, car allowance, bonus, pension, life assurance, and healthcare cover).

Apply for this job: CRA Line Manager (home-based/UK)

Contact Information:

Address:  DOCS UK
2 Globeside, Globeside Business park Marlow
SL7 1HZ
England
Reasons to work for Docs International
Tel:  +44 (0) 2380 688500
Fax:  +44 (0) 2380 688501
Website:  Visit Our Web Site

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