Pharm-Olam, LLC

Manager, Local Site Activation*

Job Locations US-NC-Raleigh-Durham | US-TX-Houston | US | CA
Job ID
2022-3061
Category
Regulatory

Why Pharm-Olam

Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

This is Important Work

Typically under the direction of a Director GCO or COM/CRM, the Manager, Local Site Activation for Site Activation Lead Staff, oversees and manages the Site Activation Lifecycle at a regional level, supporting the Site Activation project team assigned during the start up phase.

 

The Manager, Local Site Activation when conducting Local Site Activation Lead role will be responsible and accountable to keep the Site Activation Milestones on track during the course of the study(s),  therereby ensuring that expectations are met while identifying and mitigating the start up risks.

 

The Manager, Local Site Activation will provide leadership, mentorship, training and career development for assigned Site Activation Lead Staff to assure the objectives of Pharm-Olam and the sponsor are met. The Manager, Local Site Activation will provide guidance to ensure that staff fulfils responsibilities, to the company and the client, in accordance with company policies and procedures, SOPs, ICH/GCP guidelines, FDA regulations and local regulatory bodies.

 

This is a full-time, direct hire opportunity available in North America and can be remote based.We will also consider candidates interested in reduced hours. Candidates of interest should possess a strong background in clinical trial study startup / site activation management & leadership experience. #LI-Remote

Your Role

Local Site Activation Lead Role - Key Responsibilities:

 

The Key responsibilities defined below may be carried out independently or with the oversight of a Global Site Activation Manager/Sr. Manager at project level where required.

  • Responsible to attend the KOM and cover all aspects related the Site Activation.
  • Coordination of IRB/REB/RA submissions: will work alongside the GRM/LSAA Manager and Local Site Activation Staff to ensure submissions are performed according to internal and client expectations
  • Coordination of Site Contracts & Budgets: will work alongside the Global Site Contract Manager and LSAA (Budget and Contract Specialization) to oversee the negotiations of contracts and budgets with sites and internal team according to the instructions agreed at the study level, and obtain client approval on budget increase requests if outside the allowed ranges of negotiations, support the creation of the Contract and Budget Plan (CTABP)
  • Coordination of the Investigational Product Release Authorization (if applicable): will work alongside the Global Essential Document Team and Local Site Activation Staff  to meet client expectations for first patient in at study/country level
  • Plan realistic timelines for submissions and first site activation at study level, day to day management during study start-up
  • Oversee the ICF process & translations of study required documents (patient materials)
  • Participate on the development of study specific plans for start-up (Clinical Trial Agreement and Budget Plan, Regulatory and Ethics Submission Plan, Investigational Product Authorization and Release Plan): implement and monitor progress against project plans and revise as necessary
  • Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services
  • Prepare and actively participate in internal Project Review Meetings in absence of a GSAM
  • Review Site Activation budget and track out of scope budget acitivites.
  • Ensure Change Orders are requested as needed and at risk work has Senior Management approval.
  • Participate in RFP budget reviews and proposal text development
  • Present at internal and/or external meetings including Bid Defenses: prepare and deliver presentations in collaboration with relevant departments   
  • Responsible for appropriate issue escalation program to appropriate stakeholder(s)
  • Serve as key client contact for assigned project(s), managing project milestones for start-up
  • Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increased potential for repeat business
  • Perform other duties as assigned by management

Line Manager of Site Activation Lead Staff - Key Responsibilities:

  • Support the Director GCO or COM/CRM with the day-to-day functional and organizational activities of Site Activation Lead Staff.
  • Managing resourcing of Site Activation Lead Staff.
  • Provides leadership, mentorship and career development for the assigned staff, including Site Activation performance and identifying training needs.
  • Oversees and manages the assigned Site Activation Lead Staff workload.
  • Assist Site Activation Lead Staff in managing time and tasks to adhere to study budget and timelines.
  • Provide guidance to ensure that staff fulfil responsibilities, to the company and the client, in accordance with company policies and procedures, SOPs, ICH/GCP guidelines, FDA regulations and local regulatory bodies.
  • Liaises with Project Teams to ensure Site Activation Staff are fulfilling site activation requirements and meeting project and client timelines; attends assigned project team calls as needed to support the Site Activation deliverables of the project.
  • Reviews the budgeted and recorded hours to ensure they are within acceptable working limits for active studies for the assigned Site Activation Staff.
  • Participates in the interviewing of candidates and hiring of new Site Activation Staff.
  • Plans and executes Site Activation Staff training meetings, as well as contributes to and delivers training curriculum.
  • Maintains an overview of clinical studies during the Site Activation status to identify potential pitfalls and resolve project related issues on an ongoing basis.
  • Monitor and appraise the performance and compliance of Site Activation Staff in conducting their agreed objectives and/or their contractual obligations.
  • Prepare and review written objectives and conduct performance assessments of each direct report at intervals no greater than 6 months.
  • Ensure Site Activation Staff CVs, training records and job descriptions are completed and maintained up-to-date
  • Contributes to the process improvement initiatives.
  • Other responsibilities as assigned.

Required Education and Qualifications

  • Bachelor or higher university degree in life sciences, nursing or medical background preferred.
  • Minimum of 6 years relevant clinical research experience including demonstrated skills and competency in clinical project management tasks, especially regarding study start up in the pharmaceutical or biotechnology industry.
  • Working knowledge of ICH Guidelines and GCP.
  • Detailed knowledge of financial control procedures (i.e. costing systems, time reporting)
  • Working knowledge of project management processes, especially concerning study start up.
  • Experience in a leadership capacity or line management
  • Working knowledge of time and cost estimate development.
  • Attention to detail with excellent oral and written communications skills.
  • Able to thrive in a stressful environment and ability to work with changing priorities and to utilize resources effectively.
  • Able to perform well as a team member.
  • Ability to negotiate and liaise with clients in a professional manner.
  • Ability to present to internal and external clients.
  • Proficient computer skills with good working knowledge of a range of computer programs including CTMS systems.
  • Ability to travel domestically and internationally as required.

Apply Now

 

Please apply online at www.pharm-olam.com/careers

 

Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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