Job expirat
Become part of a leading Clinical Research Organization that is looking for an experienced Clinical Team Lead to join their office in Romania.
As a Clinical Team Lead you would manage the execution of the clinical component of study protocols of low to medium complexity within a region in a single continent in accordance with the scope of work and contracted timelines. You may act as a CTL for large scale projects under the supervision of a more senior CU, or Line Manager. You may also serve as a Senior Clinical Research Associate (Sr CRA) within the project or other projects as needed.
RESPONSIBILITIES
Establish appropriate clinical tools and processes for the study team to support the execution of clinical deliverable and study timelines.
Manage clinical study set-up and follow-up study activities through ongoing tracking and review of study progress. Report to appropriate clinical management and project management forums.
Collaborate with other functional groups within the company such as data management, pharmacovigilance, and biostatistics where necessary to support milestone achievement and to manager study issues and obstacles.
Provide ongoing training and support to the clinical team. Establish study tools and training materials. Conduct frequent team meetings and ensure regular communication.
Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team.
Develop the risk management plan from a clinical perspective and coordinate clinical issue escalation and resolution with the Project Manager.
Identify quality issues within the study through regular review of the clinical team communications including site communications, monitoring visit reports, data flow information and quality assurance audit findings. Implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
Track clinical budget consumption through regular review of project budget reports.
Establish customer service relationship with applicable client representative(s) as appropriate.
May conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
In depth therapeutic and protocol knowledge as provided in company training
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
Strong written and verbal communication skills including good command of English language
Excellent organizational and problem-solving skills
Effective time management skills
Strong presentation skills
Effective mentoring and training skills
Ability to lead and motivate a culturally-mixed clinical team
Ability to manage competing priorities
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in a health care or other scientific discipline or educational equivalent; 3 years clinical monitoring and one year in a project leadership role or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Frequent domestic and international travel
Hays Pharma is a leading global pharmaceutical and biotech staffing business that provides mid to upper level staff involved in drug discovery, clinical development, post-approval services and commercial activities.