Senior Site Manager

Recruiter
DOCS Global
Location
Bedfordshire
Posted
12 Oct 2018
Closes
15 Oct 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Roles & Responsibilities of the positionYour main responsibilities include;

- Site/lab assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out.
- You will partner with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Trial Manager (TM) and Global Trial Manager (GTM) to ensure
overall site management while performing trial related activities for assigned protocols.
- Fully contribute to process improvement, training and mentoring of other Site Managers.
- Ensures site staff have current GCP and necessary protocol and compound training to conduct the clinical trial.
- Contribute to site level recruitment strategy and contingency planning and implementation
- Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
- Ensure accuracy, validity and completeness of data collected at trial sites
- Responsible for the reporting of all AEs/SAEs/PQCs within the required reporting timelines and documented as appropriate.
- Maintain complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints).
- Complete visit reports and follow-up letters to investigators. Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented.
- Follows the corresponding Monitoring Guidelines for each assigned trial.Job Requirements- A Master degree in Life Sciences, Nursing, or related scientific field is required.
- A minimum of 2 years of clinical trial monitoring experience is preferred
- Oncology therapeutic area experience may be required.
- Strong knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
- Strong IT skills in appropriate software and company systems.
- Able to travel with occasional/regular overnight stay away from home depending on the region.
- Ability to work on multiple trials in parallel in different disease areasRemuneration & other details- A competitive salary and benefits package, including car allowance
- Opportunity to work with a global sponsor and develop your therapeutic area knowledge
- Great scope for training and career development
- Working within established teams, within a great company culture
- A great work/life balance

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