Pharm-Olam, LLC

Senior Manager, Local Site Activation

Job Locations US-TX-Houston | US-NC-Raleigh-Durham | US | CA
Job ID
2022-3059
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 or COM/CRM, the Senior Manager, Local Site Activation is responsible and accountable for performing, (depending on the 4 grades of specialization identified below) all related site activation activities at a local level.

 

The Senior Manager, Local Site Activation can use different tools in CTMS during the Site Activation Lifecycle and 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 Senior Manager, Local Site Activation will provide leadership, mentorship, training and career development for assigned Site Activation 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 Specializations:

 

Regulatory Authority (RA) submission/approval activities - Key Responsibilities:

  • Assist the Global Regulatory Manager (GRM) in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials and marketing applications at local level
  • Prepare, compile and submit regulatory documentation independently:
  • Manage the preparation of local clinical trial applications.
  • Ensure relevant documents are in compliance with local regulation, including but not limited to clinical trial applications, study drug labels, study drug related documentation, etc. are being provided appropriately.
  • Review and approve technical, pre-clinical and clinical reports for regulatory submissions.
  • Liaise with sponsors, regulatory and clinical consultants, and Regulatory Agencies where necessary.
  • Advise regulatory and clinical consultants where necessary.
  • Compliance review of SmPCs and review of product labels.
  • Drives interactions with regulatory authorities
  • Access regulatory agency websites and/or contact regulatory authority at regular intervals for updates on regulations, guidelines and procedures. Ensure these changes and updates are communicated and circulated as appropriate.
  • Prepare, compiling answers for questions raised by the Regulatory Agency and submit the answers independently.

Independent Ethics Committee (IEC)/ Independent Review Board (IRB) submission/approval activities - Key Responsibilities:

  • Assist the GRM in the preparation, compilation, submission and maintenance of ethical requirements documentation required by Independent Ethics Committee (IEC)/ Independent Review Board (IRB)  for clinical trials and marketing applications at local level
  • Prepare, compile and submit regulatory documentation independently:
  • To local Independent Ethics Committee (IEC)/ Independent Review Board (IRB) submission
  • Ensure relevant documents in compliance with ethical requirements, including but not limited to subject information and consent forms, patient leaflets etc., are being reviewed per local legislation and provided appropriately.
  • Advise clinical consultants where necessary.
  • Manage interactions with Ethics Committee (IEC)/ Independent Review Board (IRB)
  • Access to Ethics Committee (IEC)/ Independent Review Board (IRB) websites/platforms and/or contact Ethics Committee (IEC)/ Independent Review Board (IRB) at regular intervals for updates on regulations, guidelines and procedures. Ensure these changes and updates are communicated and circulated as appropriate.
  • Prepare and compile answers for questions raised by the Ethics Committee (IEC)/ Independent Review Board (IRB) and submit the answers independently.

Clinical Trial Agreement and Budget negotiation activities with sites - Key Responsibilities:

  • To prepare, review and negotiate Clinical Trial Agreements and budgets with sites independently.
  • Stay connected with Investigator sites, Internal personnel, Global Site Contract Manager and GRM/PM/CTL regarding the status of contracts and contract related documents.
  • Prepare and oversee preparation of contractual documents and correspondence.
  • Facilitate the indemnification process between the study sponsor and the site.
  • Responsible to arrange legal translation of the Final country CTA template.
  • Responsible for the internal review of the Country specific Site budget .
  • Reponsible to include Site-level details in each final country CTA template and site budget.
  • Responsible for sending the Site-specific CTA and site budget to site and start negotiation; ensure site changes are translated.
  • Responsible for obtaining the final/draft CTA and site budget for submission where required.
  • Responsible for obtaining Site signature as well as Sponsor/Pharm-Olam signature if applicable.
  • Responsible for the review and update of the country CTA template when an internal general update is required.

Essential Document collection activities: Submission of Essential Documents for an Investigator site and authorization for the shipment of Investigational Product to the site - Key Responsibilities:

  • Responsible for preparation of Site Specific Essential Document Package and sending to sites independently.
  • Responsible for collection and first review of Essential Documents independently.
  • Responsible to provide the Global Essential Document Reviewer with the collected documents for independent review independently.
  • Responsible to follow up with the sites all the discrepancies noted by the Global Essential Document Reviewer until resolution to authorize the shipment of Investigational Product to the site independently.

Line Manager Key Responsibilities:

  • Support the COM/CRM with the day-to-day functional and organizational activities of Local Site Activation Staff.
  • Managing resourcing of Local Site Activation Staff.
  • Provides leadership, mentorship and career development for the assigned staff, including Site Activation performance and identifying training needs.
  • Oversees and manages the assigned Local Site Activation Staff workload.
  • Assist Local Site Activation 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 Local Site Activation Lead to ensure Local 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 Local Site Activation Staff.
  • Participates in the interviewing of candidates and hiring of new Local Site Activation Staff.
  • Plans and executes Local 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 Local 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 Local 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

  • Life Science degree or equivalent qualification or certification in a related allied health profession (nursing, medical) from an appropriate accredited institution; Juris Doctor (law) degree or related experience preferred
  • More than 8 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry, preferily working with IEC/IRB
  • Experience working with contracts & budget negotiations in the pharma / biotech industry
  • Experience maintaining project documentation specific to essential documents, collection and review per ICH/GCP requirements prior to Investigational Product release to the sites in the pharmaceutical or biotechnology industry
  • 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.
  • A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines.
  • Excellent understanding and demonstrated application of Pharm-Olam SOPs, ICH/GCP, FDA and country regulations
  • A thorough knowledge of Ethics Committee (IEC)/ Independent Review Board (IRB) and reporting requirements and guidelines.
  • Experience in line managing employees
  • Strong customer service orientation
  • Demonstrated professionalism and presentation of a positive image of the company
  • Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology.
  • An advanced understanding of the drug development process.
  • Proficient Excel skills & advanced numerical skills
  • Computer skills including proficiency in Microsoft Office and CTMS
  • Effective oral and written and presentation communication skills, with the ability to communicate effectively with varied audiences
  • Effective organizational and time management skills
  • Proven flexibility and adaptability
  • Ability to work in a team and to effectively prioritize tasks
  • Strong ability to work independently and problem solve
  • Attention to detail
  • Ability to establish and maintain effective working relationships with co-workers, managers, direct reports, internal and external clients
  • 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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