Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.
This position is onsite at our Princeton, NJ facility. This person Must Have First In Human Study experience in Oncology and extensive global monitoring experience.
Reporting to the Vice President, Head of Clinical Operations, the SOL will be responsible for the planning, conduct and coordination of trial oversight activities with internal and external stakeholders to ensure quality and integrity of the data within and across Genmab clinical trials.
Supporting the Clinical Trial Manager (CTM) with identification of investigators, building relationships with investigators/trial sites and conducting sponsor site visits to support recruitment and ensure compliance with the protocol, SOPs, ICH GCP and relevant guidelines.
Supporting the CTM in securing timely delivery and review of trial related documents, plans including but not limited to master PI/ICF, training records and monitoring visit reports.
Attending PTVs and SIVs and performing ongoing co-monitoring of the trials.
Ensuring proper documentation and record management is kept on the trials at all times.
Skills & Experience
Bachelor of Science degree required; Nursing degree is a plus.
Minimum 3+ years’ experience with monitoring and/or co-monitoring of clinical trials First In Human experience in Oncology.
Preferably 3 years’ experience as Trial Manager or Lead CRA from a CRO and/or pharmaceutical company.
Extensive knowledge of working with trial oversight activities is required.
Ability to plan, organize and prioritize own tasks in a fast paced and changing environment.
Good oral and written communication skills.
Ability to work independently as well with global teams (internal and external).
Result and goal-oriented and committed to contributing to the overall success of Genmab.
Ability to travel domestically up to 10%-travel to Genmab site in Denmark up to two times per year.
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialized people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.
Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
If you would like additional information about this position before applying using the link, please contact Theresa DiBiase (firstname.lastname@example.org).
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