Date Posted:

9/27/2008

 

Job ID:

1648

 

Company:

We are a leading global clinical research organization (CRO). We have proven proficiency in supporting worldwide clinical trials for medical device, pharmaceutical and biotechnology companies. We have an influential focus in the areas of Cardiovascular Diseases, Oncology and Medical Devices. We are devoted to providing clients with crucial thinking, customer service and quality deliverables. We are committed to making sure that each clinical trial is performed to the highest possible standards.

 

Location:

Massachusetts

 

Reports To:

Director, Clinical Operations

 

Salary:

$95-$110K

 

Education:

Bachelor’s degree

 

Requirements:

Minimum 3 years direct industry experience including 1 year of project and / or staff management experience. Must have a strong understanding of Medical Terminology, Physiology, and Pathophysiology. Must have strong working knowledge of Good Clinical Practices. Must have strong management skills. Must have: strong organizational and time management skills; the ability to multi-task; the ability to work effectively in a fast-paced environment; strong written, verbal communication and diplomacy skills. Preferred Qualifications: MS; 2 years experience in project and/or staff management; 3+ years experience in a CRO; very strong management skills.

 

Duties:

The Manager, Clinical Operations manages and coordinates aspects of Clinical Operations activities including successful execution of projects, resourcing and personnel activities to assure the successful completion of projects and achievement of departmental goals; promote SOP compliance. Serves as a primary point of contact for CRA staff, clinical project managers, executive staff and clients. Coordinate all aspects of Clinical Operations including, but not limited to, maintenance and revision of standard processes and procedures; coordination of project timelines, deliverables and schedules; department budget management; communication with client, clinical project managers and CRAs to promote project schedule adherence; staff management. Review staff/department billable percentages. Assist the Director, Clinical Operations with the proposal/budget development process. Participate in internal, client/sponsor, sales, scientific and other presentations as required. Periodically review and revise: - appropriate standard operating procedures; - divisional procedures and policies. Establish standard guidelines and timelines for divisional responsibilities and modify, as needed, for each project. Assist in development of case report forms and other relevant project documents and tools. Assist in the design and implementation of data collection forms and data collection strategies. Assist business development with presentations, sales related brochures, proposals, identification of prospective clients, etc. Manage and assist CRA activities with project team members to ensure efficient clinical monitoring and effective project completion. Work closely with clinical project managers to promote operations efficiency, teamwork and high morale. Manage personnel activities and provide guidance for professional development of staff (coordinate resource distribution across projects, interviews, make hiring recommendations, lead disciplinary actions, and delivers performance reviews). Additional Duties and Responsibilities: Provides clinical project coverage for CPMs and CRAs May assist in the development, implementation and assess the training program for Clinical Research Associates in compliance with GCP and industry standards.

 

Date Posted:

9/1/2008

 

Job ID:

1644

 

Company:

We are a leading global clinical research organization (CRO). We have proven proficiency in supporting worldwide clinical trials for medical device, pharmaceutical and biotechnology companies. We have an influential focus in the areas of Cardiovascular Diseases, Oncology and Medical Devices. We are devoted to providing clients with crucial thinking, customer service and quality deliverables. We are committed to making sure that each clinical trial is performed to the highest possible standards.

 

Location:

Massachusetts

 

Reports To:

Manager Data Management

 

Salary:

65-100K

 

Education:

Bachelor’s degree or equivalent combination of education and experience.

 

Requirements:

CDM Must have a basic understanding of the clinical research development process and database design; a good understanding of the clinical data management process, physiology, pharmacology, and clinical study objectives and methodologies; good computer skills; good verbal and written communications skills; good problem-solving skills; must be detail-oriented. Preferred Qualifications: 1+ years of clinical data management experience; experience in a CRO/pharmaceutical/biotech environment.

 

Duties:

CDM reviews data; assists in database design and testing; designs CRFs and guidelines; designs and tests logic checks; generate queries for missing or discrepant data; utilizes tools/systems to code medical terms and medications; works with Clinical Monitoring, Medical Affairs, Database Development, Biometrics and Project Management personnel to resolve project related issues.

 

Date Posted:

7/10/2008

 

Job ID:

1633

 

Company:

We are a primary provider of software, calculated consulting, and regulatory services for performing clinical pharmacology development. Our database Server for the storage, management, analysis, and regulatory reporting of derivative data and models in data repositories for efficient on-site validation; and Drug Model for vibrant visualization and communication of sample-based product profiles. Our company develops and markets integrated products and services that allow pharmaceutical and biotechnology companies to attain major and lasting improvements in the development and use of therapeutic products. Company strives to help customers reduce the time, cost and risk of drug development. We enhance drug development decision-making and efficiency through our services.

 

Location:

North Carolina

 

Reports To:

VP of Operations

 

Salary:

175 to 195 k

 

Education:

Pharm D, BS or MS in Pharmacology, Chemistry, Biology, Biostatistics, Bioinformatics or other Life Sciences.

 

Requirements:

10+ years experience preferred. Proven history of successful leadership and management. Demonstrated knowledge of clinical research. Thorough understanding of statistical modeling. Ability to search large sets of data and make judgments about applicable data usage. Advanced skills in and abilities to review and QA large amounts of data required. Ability to foster proactive cross-functional working relationships within Scientific Modeling group, Marketing, Sales and Legal Departments. Excellent leadership, management, communication and interpersonal skills. Data management skills. Attention to detail.

 

Duties:

Provide primary leadership role within the Clinical Database Services group. Provide pharmaceutical based consultation to services groups. Provide vision and direction to business development activities. Develop therapeutic area monographs to assist work plan scoping. Develop budgets for developing meta-databases from public data sources. Provide expert consultation to Sales, Marketing and Legal departments. Author clinical support documentation, database overview documents and formal bibliographies associated with the completion of database deliverables. Develops and maintains applications systems for the management and analysis of data. Maintain and improve quality systems for meta-database offerings.

 

Date Posted:

5/2/2008

 

Job ID:

1618

 

Company:

We are a worldwide pharmaceutical and healthcare company. We develop, manufacture and market prescription pharmaceuticals. We offer an extensive array of medicines made to fight disease. We concentrate our resources on six therapy areas where we feel we can make the most difference. Our extensive product portfolio is targeted at these important areas and includes numerous global leaders and a number of key products.

 

Location:

UK and Sweden

 

Reports To:

Early Development Director

 

Salary:

£120,000 pa plus 20-30% bonus or in US Currency Up to $250K

 

Education:

M.D. Ideally backed up by PhD and/or research experience capable of impacting novel target discovery

 

Requirements:

Demonstrated clinical research expertise. Specialty training or board eligibility within the therapeutic area of Respiratory. Min 5 yrs. demonstrated cross-functional leadership experience within academia and ideally within industry. Extensive Drug Development Experience (> 5 years). Proven teamwork and collaboration across diverse skill sets. Ability to travel nationally and internationally. Preferred Background: 10 yrs. demonstrated success in clinical leadership positions. Successful track record in drug development, regulatory and external interactions. Experience in several organizations and geographic locations. Internal and External Contacts/Customers: Strong worldwide external awareness, good scientific and external decision-maker-networks. Regulatory and Academic Network. Credible in medical, scientific and commercial environments.

 

Duties:

Description: The Medical Science Director will deliver to the RA/TA in collaboration with Discovery & Clinical the Medical Scientific strategies for clinical components of Target Identification (TI), Target Validation (TV), Disease Area Knowledge, patient segmentation, patient stratification, personalised medicine, exploratory development clinical studies and strategies for prioritised targets, between Pre-projects and MS3. Within the Clinical Discovery Team (CDT) the Medical Science Director is the Clinical Team Leader and has accountability for the overall clinical, scientific, value content & delivery of the Medical Science components to the RA/TA and Clinical Organization. Major Responsibilities: Accountabilities: RAMT & Discovery Bodies, specifically Target Selection Committees-Input into Pre-project, MS1-MS3 & prioritisation of this portfolio. TAPT & DAST-Input into DAS & TAPT strategy. Translational Medicine Leadership Team-Provide discovery and clinical resource, support, technology access for biomarkers, imaging, safety etc TA Clinical Leadership (EDD and TACVP)-Provide Input into clinical resource requirements and budget. Clinical Project Team-Overall clinical, scientific & value content. Delivery of Medical Science components to the CDT to time & quality. Responsibilities: Responsible for the Translational Medicine Plan for Emerging Targets entering MS1 portfolio. Responsible for the clinical strategy that new targets will meet future TPP/TPC and target labelling. Responsible for the clinical documents to support MS1 transitions and any clinical documents required for the TSC. Responsible for the ethical and scientific integrity of the plans and clinical studies. Responsible with Drug safety for the risk management plan and evaluation of new targets. High level strategic external interactions including academic collaborations & key external centres required for development activities and support for the MS1-MS3 portfolio. Together with Project Co-ordination Director, support rapid implementation of agreed and budgeted plans through the CDT. Ensure project clinical strategies and plans receive peer review (TMLT) to assure quality. Support as appropriate within project during issue & crisis management as directed by EDD & VP, Clinical for TA.

 

Date Posted:

5/2/2008

 

Job ID:

1617

 

Company:

We are a worldwide pharmaceutical and healthcare company. We develop, manufacture and market prescription pharmaceuticals. We offer an extensive array of medicines made to fight disease. We concentrate our resources on six therapy areas where we feel we can make the most difference. Our extensive product portfolio is targeted at these important areas and includes numerous global leaders and a number of key products.

 

Location:

UK and Sweden

 

Reports To:

Early or Late Phase Development Director

 

Salary:

£120,000 pa plus 20-30% bonus or in US Currency Up to $250K

 

Education:

M.D.

 

Requirements:

Minimum Requirements Graduate of a recognized school of medicine with an M.D. degree or equivalent. Demonstrated clinical research expertise in Respiratory. Specialty training and board eligibility in Respiratory preferred. 5 yrs. demonstrated leadership experience. Extensive Drug Development Experience. Proven teamwork and collaboration skills. Ability to travel nationally and internationally. Preferred Background: Board certification or eligibility in (name specialty areas). 10 yrs. demonstrated leadership experience. Experience in several organizations and geographic locations. •Internal and External Contacts/Customers: Strong worldwide external awareness, good scientific and external decision-maker-networks. Regulatory and Pricing/value awareness. Credible in scientific and commercial environments.

 

Duties:

Description: The Medical Science Director will deliver to the GPT the Medical Scientific strategies for clinical components of the TPP, TPC, CDP, and core labeling texts and to provide medical input into commercial activities and the scientific component of the pricing & value strategy Within the Clinical Project Team the Medical Science Director has accountability for the overall clinical, scientific & value content and delivery of the Medical Science components to the project to time & quality. In some cases, the MSD may be appointed the CPT leader. The CPT leader role is as follows: In addition to the other aspects of the MSD role, the CPT Leader is responsible for setting up the team, defining the structure within the principles of the CPOM, and for ensuring that the team develops into an effective functioning unit while demonstrating competence against the Company Leadership Capabilities. The CPT Leader is required to be skilled in creating a productive and motivational team climate and in driving performance in order to achieve individual, team and organizational objectives. The CPT Leader is also required to be skilled in decision-making, and in ensuring that the delivery teams are appropriately empowered and are able to make decisions effectively. The CPT Leader provides the vision and direction for the team, and ensures that all parts of the wider clinical team have clear goals, charters and objectives. The CPT Leader maintains a high level view of the whole clinical program and takes overall accountability for it. The CPT Leader also ensures that team performance is appropriately recognized. Major Responsibilities: Accountabilities: Global Product Team, –Timely provision of Medical Scientific strategies for clinical components of the TPP, TPC, CDP, and core labeling texts. –Medical input into commercial activities. –Timely provision of scientific component of the pricing & value strategy. Accountable for the benefit risk assessment. Additional accountabilities when MSD is Clinical Project Team Leader:Provision of provides direct leadership to members of the CPT, and is accountable for all aspects of team formation and development of the team (see description above). Clinical Project Team: Overall clinical, scientific & value content. Delivery of Medical Science components to the project to time & quality. Responsibilities: •Responsible for the clinical strategy to meet TPP/TPC and target labelling. Responsible for the ethical and scientific integrity of the plans, studies and the product. Responsible with Drug safety for the risk management plan. High level strategic internal and external interactions including (Academic collaborations and Key Opinion Leader & key centres development and support). Together with Project Co-ordination Director, support rapid implementation of new processes & systems through their project. Ensure project clinical strategies and plans receive peer review to assure quality. Support as appropriate within project during issue & crisis management as directed by Early or Late Phase development Director.