Clinical Trial Manager

PE Global is currently recruiting for a Clinical Trials Manager (virology) for an initial 12 month contract role with a leading multinational Biotech client based in Stockley Park – hybrid (3 days in the office).

Daily rate is £351.35 PAYE or £466.60 via an umbrella company

The candidate will likely work across several studies, including involvement from study start-up through study close-out activities, and will work with the CRO to execute the study to agreed timelines and budget. The successful candidate will have the ability to work successfully with cross-functional team members globally and to manage stakeholders accordingly.

Job Responsibilities

• Provides regional management of global PIb-III studies managed by Clinical Program Manager

• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports

• Maintains study timelines

• Contributes to development of study budget

• Contributes to development of RFPs and participates in selection of CROs/vendors.

• Manages CROs/vendors

• Coordinates review of data listings and preparation of interim/final clinical study reports

• May contribute to development of abstracts, presentations, and manuscripts

• Ensures effectiveness of site budget/contract process

• Train CROs/vendors/investigators/study coordinators on study requirements.

• Conducts Monitoring/co-monitoring as required

• Assists in determining the activities to support a project’s priorities within functional area

• Coordinates and supervises all aspects of a clinical study

• May assist Clinical Operations International Therapeutic Area Leads in their duties

• Contributes to Clinical Operations International team activities & initiatives

• Collaborates with local medical affairs colleagues on country specific studies and initiatives

• Provides knowledge and expertise on country specific regulations and site experience and suitability for development studies

• May serve as a resource for others within the company for clinical trials management expertise

• Under general supervision, is able to examine functional issues from an organizational perspective

Requirements

• PharmD / PhD with 2+ years’ relevant clinical or related experience in life sciences.
• MA / MS with 3+ years’ relevant clinical or related experience in life sciences.
• BA / BS / RN with 3+ years’ relevant clinical or related experience in life sciences.
• Multiple years’ clinical or related experience in life sciences, including experience leading or managing less complex studies and project teams.
• Experience managing the work of external vendors.

Knowledge & Other Requirements

• Significant relevant experience and a BSc or nursing qualification in a relevant scientific discipline

• Previous experience in Virology areas would be advantageous

• Must have previous study management/coordination experience at Sr CTMA level

• Monitoring experience is highly desirable as co-monitoring will be required

• Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable

• Must be able to generally understand, interpret, and explain protocol requirements to others

• Must be able to prioritize multiple tasks

• Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision

• Must have a general, functional expertise to support SOP development and implementation

• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction

• Excellent teamwork, decision-making and organizational skills are key to success

• Strong communication skills

Interested candidates should submit an up to date CV.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***