|
Apply online for the
Clinical Research Manager
position and advance your career in the
Pharmaceutical industry today.
|
Clinical Research Manager : GlaxoSmithKline
|
| Job Number |
71864 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
King of Prussia
Pennsylvania
|
| Salary (year) |
|
| Experience |
2 to 5 Years |
| Start Date |
12/1/2011 |
| Industry |
Pharmaceutical |
| Job Type |
Clinical |
| Relocation |
Not Required |
|
View all jobs from GlaxoSmithKline |
|
|
|
| Apply Online |
| What Does Your Boss Say About You? |
| Description |
Basic Qualification
Undergraduate degree or equivalent in a science or health related discipline.
Significant clinical drug development experience within the Pharmaceutical Industry or related experience with specific scientific knowledge and expertise in drug development (Type 2 Diabetes preferred), familiarity with GCP, specific country regulations and ICH guidelines. Knowledge of GSK SOPs and processes, experience working with CROs. Expertise to include project responsibility, protocol, report and regulatory submission writing and operational aspects of drug development..
Clinical experience in preparation and participation of regulatory filings and meetings.
Demonstrated expertise need to include; protocol development, CRF design, investigator recruitment, budget and contract negotiations, Investigator Meeting presentations, study center evaluation, initiation, and operational oversight of trials to ensure quality deliverables per study timelines. Experience with review of data listings and patient profiles for inconsistencies, performance of SAE reconciliation with CRFs and preparation of safety narratives for -Clinical Study Reports.
Demonstrated track record of applying expertise in his/her discipline to move a project through the drug development process.
Demonstrated general knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects.
At least 5-10 or more years of relevant industry expertise.
Details
Provides a leadership role in managing multi-national Phase I through Phase IV clinical research trials across all functional areas . This position drives the scientific and operational aspects of ongoing studies and / or projects to meet the goals of quality, time, and cost. Activities include protocol development, CRF design, investigator recruitment, budget and contract negotiations, Investigator Meeting presentations, study center evaluation, initiation, and operational oversight.
Supports/participates in the end-to-end clinical development process for multiple studies. With minimal oversight, ensures consistency with clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management.
Builds and maintains networks and positively influences at project and department level (internal/external including regulators, payors, consultants, investigators, commercial staff and senior management engagement) in order to deliver clinical programs and align to business strategy.
Demonstrates clear matrix leadership; encourages team work across projects and within line. Actively promotes and utilizes skills and contributions of others within project and line.
Encourages others within matrix and line teams to seek alternative perspectives and develop solutions. Proactively generates ideas for improvements and takes actions to solve problems and achieve goals; suggests new ways to apply existing knowledge.
Encourages dissemination of learnings and implements improvements across projects and line to ensure quality of deliverables.
Explores positions and alternatives to reach agreements and solutions; presents clear arguments to gain acceptance of ideas and influences outcomes to meet organizational objectives; demonstrates effective ability to influence others at project, departmental and inter-departmental levels.
Allocates decision-making authority and task responsibilities to appropriate direct reports and/or team members across projects, utilizing their time, skills and potential effectively; promotes a culture of empowerment within clearly defined areas of responsibility.
Uses appropriate interpersonal styles and methods to guide team towards objectives; modifies behavior according to tasks and individuals.
Facilitates development of others’ knowledge and skills; provides timely feedback and guidance to help them reach their goals. |
|
| Requirements |
Preferred Qualification
Advanced understanding of R&D and drug development process.
Understands the key components, deliverables and steps needed to achieve a reimbursable file.
Able to complete the following elements of clinical study: design, development, implementation management, analysis, interpretation and reporting with minimal supervision.
Able to interpret impact of the external regulatory environment on study delivery, may independently formulate strategy to react, and implement actions.
Demonstrated general knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and or market support.
Understanding of the impact of decisions and maintains awareness of business drivers and alternative solutions for project delivery.
Advanced understanding of clinical practices. Able to complete the following elements of clinical study: design, development, implementation, management, analysis, interpretation and reporting with minimal supervision.
Advanced knowledge of financial systems, processes, and reports.
Demonstrated ability to develop self and others by providing coaching and constructive feedback to reports, peers, and managers.
Established track record of generating alternative solutions and perspectives at project and line level.
Demonstrated track record of quality decision-making and creative problem resolution that impacts program / project direction.
Possesses highly effective communication skills at all levels and is capable of adapting messages for different audiences inc CROs. |
|
| Contact Info |
|
|
|
Apply online at company website |
|
Find More Pharmaceutical Jobs in the Pharmaceutical industry.
|
|