高级临床项目经理

**Remote in the Northeastern US**
Pay: $150,000 - $175,00 +Bonus
Uniphar – Who we are.
With a workforce of more than 3500 employees spread across Ireland, United Kingdom, Mainland Europe, MENA, and the USA, Uniphar is a trusted global partner to pharma and MedTech manufacturers, working to improve patient access to medicines around the world. Uniphar provides outsourced and specialized services to its clients, leveraging strong relationships with 200+ of the world’s best-known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our highly expert teams. Uniphar is organized into three key divisions: Supply Chain & Retail, Global Sourcing, and Pharma. This position will support human resources across the US division.
Click here to find out more: About Us - Who we are | Uniphar
Culture at Uniphar
Uniphar is a combination of many businesses each with their own identity, culture, values, and ways of working. Uniphar lives and breathes four key pillars which unpin and support our culture.
We have a people first approach - we do the right thing. We support an entrepreneurial spirit where adaptability, commitment & resilience is embodied in our way of working. We have a Common Purpose that connects our diversified businesses and people. Finally, Trust is at the heart of how we operate.
Everything Uniphar does is enabled by our people, and, as we continue to grow domestically and internationally, we become more diverse. This diversity fuels our business and culture.
Sustainability
Sustainability is at the core of what we do and is deeply embedded in our business strategy. We want to contribute positively to the people and the world around us. Running our business in a sustainable way ensures that Uniphar will continue to prosper in the long-term. We are focused on ensuring that each of the five pillars of our sustainability strategy are a fundamental part of our decision-making process.
Role Overview:
The Senior Clinical Project Manager (Sr CPM) will be responsible for the overall execution of clinical operations activities on behalf of Uniphar Development Partners for trials spanning Phase I through Phase Ill.
The Sr CPM serves as the primary contact to Contract Research Organizations (CROs), Service Providers, site investigators, study personnel, as well as internal Uniphar Development functional areas, the Product Development Team (PDT) members, and the Partner to relay trial progress, status and/or issues associated with the daily operations of one or more clinical trials. The Sr CPM will be responsible for all aspects of the clinical trial from pre-study planning, protocol review, management of CRO(s) and other 'Service Providers, through clinical study report finalization for regulatory submission. The Sr CPM will ensure trial conductivity follows ICH-GCP, FDA/EMA, or other regulatory health authorities, and Standard Operating Procedures (SOPs), as applicable. The Sr CPM will also ensure all operational trial deliverables are met according to project agreement(s), timelines, budget, operational procedures, and quality standards.
Key Responsibilities:

• Manages all study-related activities to meet defined study timelines, stated goals, budgets, while ensuring GCP/ICH guidelines and the relevant SOPs are met

• Responsible for vendor management as related to the study, in particular, oversight of CRO activities related to conduct of clinical studies

• Leads internal study team meeting with functional area representatives

• Responsible for leading and coordinating the development of study-related documents such as Clinical Project Plans, Informed Consent, Case Report Forms (CRFs), Monitoring Plan, Patient Diary, CRF Completion Guidelines, Safety Management Plans, Communication Plans, Clinical Study Quality Plans, and other relevant study plans and charters

• Maintains primary responsibility for the content of all study-related operational manuals, such as study operations manuals, pharmacy manual, and Service Provider manuals

• Oversees investigator recruitment/selection and the conduct of trials at investigative sites

• Participate as necessary in monitoring visits (co-monitoring), reviews monitoring visit reports and letters, and ensures CRO quality within trials

• Plans, executes, and leads Investigators' Meetings, if applicable; or may lead Site Initiation Visits, Clinical Research Associate (CRA)/Monitor training, and/or any other study related training

• Tracks study progress ensuring timely data collection, query resolution, monitoring, protocol adherence through the review of protocol deviations and, in collaboration with data management, through internal listings reviews

• Proactively escalates project-related issues to the Senior Management, or designee, to ensure timely resolution of issues

• Responsible for the quality control of clinical data of the assigned studies / projects. Develops correction action plans, as necessary to ensure integrity of clinical data

• Provides Senior Management with regular study updates/status reports on study execution

• Contributes to knowledge management within Clinical Operations, proactively identifies potential study issues/risks and recommends/implements solutions, may lead lessons learned from previous studies to be considered in new study design and implementation

• Supports the preparation of standard operating procedures within Uniphar Development for management of clinical programs

• Assists in the planning of Data (Safety) Monitoring Boards, Safety Monitoring Committees, or other data review committees

• Participation in qualification/audit activities of CROs

• Reviews and provides input to vendor contracts and may contribute to contract and budget re-negotiation efforts

• Manages invoice reconciliation from all Service Providers

• Works closely with Uniphar Developments Project Management & Planning (PM&P) to forecast budgets (actual vs. projected) on a periodic basis, including budgets provided by Service Providers; provides input to the integrated study timelines

• May be assigned sub-projects and may perform other duties as assigned by Uniphar Development Senior Management or designee

Qualifications:

• BS/BA degree or equivalent (background in life sciences preferred). Advanced degree is preferred.

• Eight or more years of clinical trial research management experience in a pharmaceutical, biotechnology or CRO setting with at least 2 years of project management experience; at least 4 years monitoring experience, with ability to independently perform all types of monitoring visits

• Demonstrated experience in managing multiple or complex projects across Phase I through Ill, including global clinical trials with multiple-CRO partners preferred, from start-up to database-lock

• Experience in management of CRO's, Service Providers, and contractors; with previous experience managing vendor contracts and budgets preferred

• Strong understanding and knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/lCH/GCP guidelines, is required

• Ability to work effectively (interpersonal, relationship management) with the study team, cross functional team members and external partners/Service Providers

• Strong operational, management skills with attention to detail, with excellent communication skills

• Requires proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project

Organizational Relationships:

• DIRECT REPORTS: 0-2 individuals

• Frequent interaction with internal and external staff, and Uniphar Development Senior Management.

• Frequent interactions with internal and external groups as a project management representative.

• Interactions concerning contract and budget re-negotiations.

Physical Requirements:
Position requires substantial use of telephone and face-to-face interactions, which require accurate perception of speech. Position also requires extensive computer usage involving repetitive motions with fingers. Willingness to travel up to 20%, depending on assigned responsibilities.
Equal Opportunity Employer
Uniphar recognizes the right of an individual to work and to advance on the basis of merit, ability, and potential. It is the policy of Uniphar to ensure that job applicants are considered, and that employees are treated during employment, without regard to their race, color, religion, creed, sex, national origin, age, physical or mental disability, veteran status or Vietnam-Era veteran status, citizenship, marital status, domestic partnership status, familial status, gender identity, sexual orientation, legally protected medical condition (including pregnancy, childbirth, or related medical condition), genetic characteristics or other characteristic, condition or classification protected by federal, state, or local law. Uniphar is committed to the principles of equal opportunity and resolves to ensure equal opportunity in all employment practices.
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this position.
Originally posted on Himalayas