.. Repayment Programs. The Staff Accountant performs routine financial and Accounting tasks for the organization. Benefits 403B Dental insurance Disability .. accuracy and completeness. Assist with the operations of Accounts Payable. Prepare monthly bank reconciliations for accounts ensuring transactions are .. read more
CLINICAL RESEARCH MANAGER (Hybrid role) *Candidate should live in a commutable distance from the greater Boston area or NYC. Amount of days in the office is flexible. Our client has an exciting new position for a
Clinical Research Manager
for a
Phase II and III
clinical study in the field of
Nuclear Medicine
and
Oncology
in the USA. The company is expanding their clinical development program of new
Radiopharmaceuticals
from Europe to the USA. If you want to become a part of our young and motivated team and if you are ready for a new challenge, we are looking forward to receiving your resume! Job Summary: Coordination and implementation of
phase III
related activities with internal (EU development team, study physician) and external partners (e.g., biostatistics, reimbursement, regulatory). Independent, quality-assured, and timely planning, coordination, implementation, monitoring and evaluation of international, multicenter phase III study in the USA. Preparation (in collaboration with the clinical development team) of development plans, study protocols, study-related supporting documents as well as regulatory documents (CTAs, IND, Investigators Brochure, briefing book documents) Coordinating and crafting of interim reports and final study reports Support activities for the New Drug Application of their radiopharmaceutical tracers in the US. Monitoring and compliance with quality and budget targets (in cooperation with the European Clinical Department) Supervision (remote and in-person) of participating study centers Presentation of the company at scientific congresses Preparation and follow-up of internal and external meetings and reporting Strong interaction with Departments in Germany to cross-link European activities to the Clinical development in the USA. Approximate 20% travel time Job Requirements: Minimum of a Bachelor degree, Ph.D. preferred, in medical or natural sciences or equivalent education/experience in the medical or natural science subjects. Minimum of 5 years experience working in a
Clinical Research Manager
or
Clinical Project Manager
role with relevant experience. Proactive, reliable, and goal-oriented work ethic, attention to detail. Very good written and spoken English. German is a plus. A work permit in USA is a must. Ability to manage multiple projects in parallel and prioritize across study, regulatory, and company goals. Strong industry experience in the field of
clinical studies in the USA
is a must. Experience with
radiopharmaceuticals
is highly desirable. Experience in
endocrinology/cardiovascular
therapeutic space. Experience with
FDA
and
US
requirements for the conduct of clinical studies is a must. P hase II and Phase III
experience required. Proactive, reliable, and goal-oriented way of working Agile thinking and acting, interest in new topics in an ambitious pharmaceutical company that maintains its start-up spirit. They offer: Multi-disciplinary international project management managing diverse relationships. We offer a dynamic and ambitious environment with a wide variety of learning and development opportunities. Incentives include a flexible working environment (e.g., hybrid working) and a steep learning curve in radiopharmaceutical research in an agile team. Benefits: Performance Bonus 17 days PTO to start plus holidays 401K Healthcare benefits and more. Exciting job opportunity with project responsibilities and freedom for professional growths and acquisition of new skills
Clinical Research Manager
for a
Phase II and III
clinical study in the field of
Nuclear Medicine
and
Oncology
in the USA. The company is expanding their clinical development program of new
Radiopharmaceuticals
from Europe to the USA. If you want to become a part of our young and motivated team and if you are ready for a new challenge, we are looking forward to receiving your resume! Job Summary: Coordination and implementation of
phase III
related activities with internal (EU development team, study physician) and external partners (e.g., biostatistics, reimbursement, regulatory). Independent, quality-assured, and timely planning, coordination, implementation, monitoring and evaluation of international, multicenter phase III study in the USA. Preparation (in collaboration with the clinical development team) of development plans, study protocols, study-related supporting documents as well as regulatory documents (CTAs, IND, Investigators Brochure, briefing book documents) Coordinating and crafting of interim reports and final study reports Support activities for the New Drug Application of their radiopharmaceutical tracers in the US. Monitoring and compliance with quality and budget targets (in cooperation with the European Clinical Department) Supervision (remote and in-person) of participating study centers Presentation of the company at scientific congresses Preparation and follow-up of internal and external meetings and reporting Strong interaction with Departments in Germany to cross-link European activities to the Clinical development in the USA. Approximate 20% travel time Job Requirements: Minimum of a Bachelor degree, Ph.D. preferred, in medical or natural sciences or equivalent education/experience in the medical or natural science subjects. Minimum of 5 years experience working in a
Clinical Research Manager
or
Clinical Project Manager
role with relevant experience. Proactive, reliable, and goal-oriented work ethic, attention to detail. Very good written and spoken English. German is a plus. A work permit in USA is a must. Ability to manage multiple projects in parallel and prioritize across study, regulatory, and company goals. Strong industry experience in the field of
clinical studies in the USA
is a must. Experience with
radiopharmaceuticals
is highly desirable. Experience in
endocrinology/cardiovascular
therapeutic space. Experience with
FDA
and
US
requirements for the conduct of clinical studies is a must. P hase II and Phase III
experience required. Proactive, reliable, and goal-oriented way of working Agile thinking and acting, interest in new topics in an ambitious pharmaceutical company that maintains its start-up spirit. They offer: Multi-disciplinary international project management managing diverse relationships. We offer a dynamic and ambitious environment with a wide variety of learning and development opportunities. Incentives include a flexible working environment (e.g., hybrid working) and a steep learning curve in radiopharmaceutical research in an agile team. Benefits: Performance Bonus 17 days PTO to start plus holidays 401K Healthcare benefits and more. Exciting job opportunity with project responsibilities and freedom for professional growths and acquisition of new skills