- Location:
- Gaithersburg, MD 20878
- Status:
- Full Time, Employee
- Job Category:
- Biotech/R&D/Science
Training Specialist III (Clinical Research)
Title: Training Specialist III
Location: MD Gaithersburg - Corporate Headquarters
Req: 01801
Position Summary:
The Training Specialist III (TS III) position will support the Medical Organization Training and Standards Department (MOTSD) team in delivery of quality training services to the Medical Organization (MO). This position will provide for all MO Functional Areas comprising seven departments including Clinical Development Clinical Operations Product Leadership Project Management Medical Administration Medical and Scientific Affairs and Patient Safety.
Responsibilities include: providing administrative assistance to on-boarding of new employees Good Clinical Practice (GCP) training core curriculum training record documentation training and the creating and developing job-related training (e.g. training concerning procedures self-governance documents technology/systems etc.).
The Training Specialist III responds to customer requests both independently and as part of a team. The TS III manages increased responsibilities and works with limited supervision. S/he demonstrates attention to detail and to on-time delivery of MOTSD services.
The Training Specialist III possesses a good working knowledge of the drug development process key regulations and guidances that govern clinical research (e.g. Food and Drug Administration (FDA) Code of Federal Regulations (CFRs) International Conference on Harmonization (ICH) and European Union (EU) Directives and other international standards. The TSIII is familiar with Good Clinical Practices (GCPs) and is able to offer training as appropriate related to applicable laws statutes and statutory instruments regulations codes of practice guidelines and/or policies ¡V for countries in which MedImmune is conducting clinical trials and/or marketing products. S/he is experienced with problem solving prioritizing process mapping and e-clinical technology. The TS III works in accordance with corporate best business practices operational excellence initiatives and compliance/quality assurance expectations.
Major Duties and Responsibilities (including supervising others):
The major duties and responsibilities of the Training Specialist III include but are not limited to:
Provides team leadership ¡§hands-on¡¨ direction and guidance ¡V adhering to project timelines set milestone dates and deliverables.
Serves in the Training Liaison role providing deliverables and when called upon leads the team through the 5-step Operational Excellence (OE) process (DMAIC) to achieve specified goals.
Assists MOTSD management in procedural document (MSPSOP etc.) development including design of related training and creation of Knowledge Assessments (KAs) drafting of computer-based training (CBTs) providing subject matter expert (SME) instructor-led training support and facilitating of training events.
Reaches out to customers to address identified needs in a positive responsive timely and professional manner; handles promptly customer requests and as necessary forwards training requests and questions to MOTSD management; encourages Training Requests (TRs) and provides input into the development of Training Plan (TP) solutions.
Participates in processing and fulfilling Training Requests/Training Plans for MO customers and recommends training solutions for GCP compliancy requirements correction action plans continuing improvement process ideas and professional advancements.
Works collaboratively with MOTSD team members participating and supporting the completion of training initiatives.
Designs develops and delivers training/education curricula comprised of MO corporate curriculum job-related core curriculum clinical trial conduct technology/systems training and drug development (e.g. FDA CFR ICH and GCP) topics.
Participates in monthly departmental discussions and provides input regarding MOTSD objectives; collaborates in the planning scheduling and managing of assigned objectives.
Represents as requested the MOTSD training-professional at meetings.
Employs during the design development and delivery of training ¡V personal subject matter expertise knowledge and experience with regards to topics of clinical trial conduct and drug development (including FDA OHRP EU Directive and ICH topics).
Manages assigned goals and objectives for the Clinical Development and Operations (CDO) yearly operating plan that revolves around the following categories:
o GCP Compliance
o Controlled Documents and Procedural Training
o Migrations & Upgrades
o Design and Implementation
o Vendor Selection & Management
o Training Requests/Training Plans
o Technology and Systems Training
o Other Training Offerings
Implements all training duties assigned by direct Supervisor and/or MOTSD Manager/Director.
Educations:
Education: This position requires a Bachelors/Masters degree or equivalent in a life science education or engineering discipline ¡V preferred MS MD or PhD in education or medicinal a
CLICK HERE TO APPLY
MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
Location: MD Gaithersburg - Corporate Headquarters
Req: 01801
Position Summary:
The Training Specialist III (TS III) position will support the Medical Organization Training and Standards Department (MOTSD) team in delivery of quality training services to the Medical Organization (MO). This position will provide for all MO Functional Areas comprising seven departments including Clinical Development Clinical Operations Product Leadership Project Management Medical Administration Medical and Scientific Affairs and Patient Safety.
Responsibilities include: providing administrative assistance to on-boarding of new employees Good Clinical Practice (GCP) training core curriculum training record documentation training and the creating and developing job-related training (e.g. training concerning procedures self-governance documents technology/systems etc.).
The Training Specialist III responds to customer requests both independently and as part of a team. The TS III manages increased responsibilities and works with limited supervision. S/he demonstrates attention to detail and to on-time delivery of MOTSD services.
The Training Specialist III possesses a good working knowledge of the drug development process key regulations and guidances that govern clinical research (e.g. Food and Drug Administration (FDA) Code of Federal Regulations (CFRs) International Conference on Harmonization (ICH) and European Union (EU) Directives and other international standards. The TSIII is familiar with Good Clinical Practices (GCPs) and is able to offer training as appropriate related to applicable laws statutes and statutory instruments regulations codes of practice guidelines and/or policies ¡V for countries in which MedImmune is conducting clinical trials and/or marketing products. S/he is experienced with problem solving prioritizing process mapping and e-clinical technology. The TS III works in accordance with corporate best business practices operational excellence initiatives and compliance/quality assurance expectations.
Major Duties and Responsibilities (including supervising others):
The major duties and responsibilities of the Training Specialist III include but are not limited to:
Provides team leadership ¡§hands-on¡¨ direction and guidance ¡V adhering to project timelines set milestone dates and deliverables.
Serves in the Training Liaison role providing deliverables and when called upon leads the team through the 5-step Operational Excellence (OE) process (DMAIC) to achieve specified goals.
Assists MOTSD management in procedural document (MSPSOP etc.) development including design of related training and creation of Knowledge Assessments (KAs) drafting of computer-based training (CBTs) providing subject matter expert (SME) instructor-led training support and facilitating of training events.
Reaches out to customers to address identified needs in a positive responsive timely and professional manner; handles promptly customer requests and as necessary forwards training requests and questions to MOTSD management; encourages Training Requests (TRs) and provides input into the development of Training Plan (TP) solutions.
Participates in processing and fulfilling Training Requests/Training Plans for MO customers and recommends training solutions for GCP compliancy requirements correction action plans continuing improvement process ideas and professional advancements.
Works collaboratively with MOTSD team members participating and supporting the completion of training initiatives.
Designs develops and delivers training/education curricula comprised of MO corporate curriculum job-related core curriculum clinical trial conduct technology/systems training and drug development (e.g. FDA CFR ICH and GCP) topics.
Participates in monthly departmental discussions and provides input regarding MOTSD objectives; collaborates in the planning scheduling and managing of assigned objectives.
Represents as requested the MOTSD training-professional at meetings.
Employs during the design development and delivery of training ¡V personal subject matter expertise knowledge and experience with regards to topics of clinical trial conduct and drug development (including FDA OHRP EU Directive and ICH topics).
Manages assigned goals and objectives for the Clinical Development and Operations (CDO) yearly operating plan that revolves around the following categories:
o GCP Compliance
o Controlled Documents and Procedural Training
o Migrations & Upgrades
o Design and Implementation
o Vendor Selection & Management
o Training Requests/Training Plans
o Technology and Systems Training
o Other Training Offerings
Implements all training duties assigned by direct Supervisor and/or MOTSD Manager/Director.
Educations:
Education: This position requires a Bachelors/Masters degree or equivalent in a life science education or engineering discipline ¡V preferred MS MD or PhD in education or medicinal a
CLICK HERE TO APPLY
MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
