|Reference # : ||21-00239
||Title : ||Clinical Scientist with Global Drug Development|
Lawrence Township, NJ
|Position Type : ||Contract|
|Experience Level : ||
||Start Date : ||01/25/2021
| Description |
CLINICAL SCIENTIST WITH GLOBAL DRUG DEVELOPMENT
LAWRENCE TOWNSHIP, NJ
- Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials.
- Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision.
- Provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership).
- Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team members.
- May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning).
- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members.
- Plan and lead the implementation all study startup/conduct/close-out activities as applicable.
- Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead).
- Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing).
- Site-facing activities such as training and serving as primary contact for clinical questions.
- Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team.
- Clinical data trend identification; provide trends and escalate questions to Medical Monitor.
- Develop clinical narrative plan; review clinical narratives.
- Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
- Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities.
- Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses).
- Collaborate and serve as primary liaison between external partners for scientific advice.
This 6+ month position starts ASAP.
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred).
- 5+ years of experience in clinical science, clinical research, or equivalent.
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation.
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
- Excellent verbal, written, communication and interpersonal skills.
- Must be able to effectively communicate and collaborate across functions and job levels.
- Ability to assimilate technical information quickly.
- Routinely takes initiative.
- Strong sense of teamwork; ability to lead team activities.
- Proficient in Medical Terminology and medical writing skills.
- Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile).
- Proficient critical thinking, problem solving, decision making skills.
- Understanding of functional and cross-functional relationships.
- Commitment to Quality.
- Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
- Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals).
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools.
- Domestic and International travel may be required.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: firstname.lastname@example.org
ALPHA'S REQUIREMENT #21-00239
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE