Job Description

Requirements

Prefer candidate with previous CRO experience. Previous clinical trial management experience required. Candidates should have experience with global roles and program-level oversight. Early Phase Oncology. (Solid Tumor and Hematology) experience required.

Full job description provided upon request.

The Associate Clinical Monitoring Director is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies, or a program of studies. Associate Clinical Monitoring Directors ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams to ensure projects meet delivery requirements.

The Associate Clinical Monitoring Director responsibilities are for all activities related to the implementation and execution of clinical studies to include  but not limited to the following: client and team related duties; coordinate and oversee daily operations of the clinical monitoring team; and manage project milestones. Additionally, they are responsible for the CRA and regional CTM performance as well as review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.

Qualified applicants must meet the following:

KNOWLEDGE, SKILLS & ABILITIES:

Thorough knowledge of clinical research process, including medical and therapeutic areas, phases and medical terminology.
Prior global program/project oversight experience, including basic understanding of EU, UK and NA country regulations.
Prior experience as a Clinical Trial Manager.
Prior experience as a Clinical Research Associate.
Excellent communication skills (verbal and written) with ability to express complex ideas.
Strong presentation skills.
Strong negotiation skills with the ability to communicate difficult concepts clearly.
Excellent organizational skills and proficient at multi-tasking with strong attention to detail.
Strong interpersonal skills, with flexibility to adapt to changing situations.
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
Prior experience leading, liaising and coordinating cross-functional project teams required.
Ability to lead, motivate and coordinate local and virtual teams.
Ability to manage multiple priorities within various clinical trials.
Ability to reason independently and recommend specific solutions in clinical settings.
Ability to delegate, effectively prioritizing own and workload of project team members.
Understanding of basic data processing functions, including electronic data capture; ability to effectively use automated systems and computerized applications.
Possesses cross cultural awareness and is able to adapt appropriately.
Working knowledge of current ICH GCP guidelines and applicable regulations.
Able to mentor CRAs and Clinical Trial Managers.
Able to qualify for a major credit card.
Valid driver’s license; ability to rent automobile.
Willingness and ability to travel domestically and internationally, as required.

MINIMUM RECRUITMENT STANDARDS

BS/BA (or equivalent) in one of the life sciences with a minimum of 6 years direct experience in clinical studies or equivalent level of education and experience. 
Minimum of 6 years as a Clinical Monitor/CRA or equivalent industry experience, as well as experience in data handling or analysis. 
Minimum of 5 years as a successful Lead CRA or Clinical Trial Manager or equivalent industry experience.
Prior global management/oversight experience required.
Ability to work independently, prioritize and work with a matrix team environment is essential. 
Working knowledge of Word and Excel. 
Prior experience in electronic data capture (EDC) preferred.