Senior Clinical Trials Management Associate
Kite Pharma · Parsippany, NJ · 1 wk ago
On-siteAnalyst$115k–$149k/yrFull-time
Job Description
The Senior Clinical Trials Management Associate is a primarily in-house sponsor position who will oversee multiple aspects of clinical trial conduct including study start-up, document generation and review, tracking of samples enrollment of study participants, and management of vendors.
- Prepares and/or reviews study-related or essential study start-up documents as they relate to the supported clinical trials as delegated by the study manager (e.g., Clinical protocols, Informed Consent Forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
- Works with multiple contract research organizations to communicate detailed timelines and ensure that transferred obligations and performance expectations are met.
- Provides corrective instruction, as necessary, when performance expectations are not being met.
- Attends internal team and other meetings as required.
- Provides training, as necessary, at investigator meetings and other trial-specific meetings such as site initiation visits and monthly teleconferences.
- Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations.
- Proactively identifies potential study issues/risks and recommends/implements solutions; ensures issues are escalated as appropriate to Senior Manager.
- Prepares metrics and updates to key deliverables for management.
- Aids in the resolution of clinical trial queries and data review for interim analysis, primary analysis and final database locks.
- Prepares site newsletters and other correspondence related to clinical trial conduct (eg, best practices and lessons learned, frequently asked questions) in collaboration with the study team.
- Aids in the resolution of routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol.
- Might lead less complex studies and/or manage components of more complex studies as a member of the study team.
- May participate in department initiatives or special projects, such as developing new tools or processes.
- Ability to coach less experienced colleagues in solving problems.
Basic Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Preferred Qualifications
- Bachelor’s degree in nursing, science or health related field required with at least five years of related experience.
- At least three years of clinical trial experience with oncology, hematology or related therapeutic area experience considered a plus.
Other Duties
- May lead less complex studies and/or manage components of more complex studies as a member of the study team.
- May participate in department initiatives or special projects, such as developing new tools or processes.
- Ability to coach less experienced colleagues in solving problems.
Section Not Present
Section Not Present
Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Basic Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Preferred Qualifications
- Bachelor’s degree in nursing, science or health related field required with at least five years of related experience.
- At least three years of clinical trial experience with oncology, hematology or related therapeutic area experience considered a plus.
Section Not Present
Section Not Present
Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Basic Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Preferred Qualifications
- Bachelor’s degree in nursing, science or health related field required with at least five years of related experience.
- At least three years of clinical trial experience with oncology, hematology or related therapeutic area experience considered a plus.
Section Not Present
Section Not Present
Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Basic Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Preferred Qualifications
- Bachelor’s degree in nursing, science or health related field required with at least five years of related experience.
- At least three years of clinical trial experience with oncology, hematology or related therapeutic area experience considered a plus.
Section Not Present
Section Not Present
Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Basic Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Preferred Qualifications
- Bachelor’s degree in nursing, science or health related field required with at least five years of related experience.
- At least three years of clinical trial experience with oncology, hematology or related therapeutic area experience considered a plus.
Section Not Present
Section Not Present
Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Basic Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Preferred Qualifications
- Bachelor’s degree in nursing, science or health related field required with at least five years of related experience.
- At least three years of clinical trial experience with oncology, hematology or related therapeutic area experience considered a plus.
Section Not Present
Section Not Present
Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Basic Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Preferred Qualifications
- Bachelor’s degree in nursing, science or health related field required with at least five years of related experience.
- At least three years of clinical trial experience with oncology, hematology or related therapeutic area experience considered a plus.
Section Not Present
Section Not Present
Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Basic Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Preferred Qualifications
- Bachelor’s degree in nursing, science or health related field required with at least five years of related experience.
- At least three years of clinical trial experience with oncology, hematology or related therapeutic area experience considered a plus.
Section Not Present
Section Not Present
Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Basic Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Preferred Qualifications
- Bachelor’s degree in nursing, science or health related field required with at least five years of related experience.
- At least three years of clinical trial experience with oncology, hematology or related therapeutic area experience considered a plus.
Section Not Present
Section Not Present
Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Basic Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – OR
- MS/MA in nursing, science or health related field and 2 years of related experience
Preferred Qualifications
- Bachelor’s degree in nursing, science or health related field required with at least five years of related experience.
- At least three years of clinical trial experience with oncology, hematology or related therapeutic area experience considered a plus.
Section Not Present
Section Not Present
Qualifications
- BS/BA in nursing, science or health