EIEN BIOSCIENCES Looking for Clinical Project Manager/ Sr. Project Manager (Phase IV) – Non IT at Mumbai, Maharashtra Full Time

Clinical Project Manager/ Sr. Project Manager (Phase IV)

Hybrid working

The Clinical Project Manager at Eien Biosciences (Clinical Research Organization) is responsible for the planning, implementation and conduct of clinical trials in Phase III/IV in India. The Manager provides leadership within the department and makes recommendations with regards to the operational aspects of executing clinical development deliverables.

Clinical Trial Management Responsibilities:

• Liaise with Strategic Clinical outsourcing and participate in sponsor bid defense meetings and creation of scope of work, budgets, performance and issue resolution
• Manages the overall budgeting activity of the groups – annual and long range forecast
• Participate in program strategy meetings, ad hoc clinical operations’ initiatives and programs as assigned
• Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines
• Serve as the clinical operations point person managing protocol execution.
• Ensures the timely execution of clinical trials with a focus on quality deliverables for an entire therapeutic group within a region.
• Facilitates hand-off meetings and kick-off meetings to identify potential risks and work with the project team to develop and communicate contingency plans.
• Ensures project risks and potential contingencies impacting time/quality/cost of deliverables are discussed with Senior Management through appropriate escalation pathways.
• Reviews and assesses project profitability through the identification of “out of scope” activity in a timely manner and supporting follow through on all aspects of contract modification.
• Ensure trial adherence to ICH/GCP and local regulations and company specific SOPs
• Assist with training and mentoring of internal clinical operations staff
• Assist in preparation of clinical documentation for regulatory submissions/updates as appropriate.
• Oversees the review and approval of clinical monitoring visit reports and ensures that all outstanding follow-up items are closed out in a timely manner.
• Review and provide input for reports and clinical documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates
• Manage escalation of study related issues and establish appropriate course of action with Senior Management
• Liaises with the clinical supply chain lead to ensure forecasting of clinical and non-clinical supplies accurately reflects protocol/trial needs
• Ensure that the Clinical Trial Master File (TMF) is set up and maintained appropriately throughout the trial
• Conduct periodic reviews of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed
• Participate and respond to Quality Assurance and/or regulatory authority inspection audits
• Ensures quality clinical data review and data integrity for assigned clinical trial(s)
• Manage vendors and consultants that are involved with the clinical trial and program

Cross Functional Mentoring and Leadership:

• Work cross-functionally to ensure clinical program timelines and goals are met
• Provide study-specific mentoring and line management for junior team members, as appropriate
• Assume leadership role in operational improvement initiatives (e.g. SOP development, training etc.)
• Communicates with sponsor(s) regularly to obtain direction and feedback on implementing scope of work as well as performance to date. Identifies unusual or significant problems encountered during the course of a clinical trial and proposes strategies for preventing or correcting significant problems.

Knowledge, Skills and Abilities:

• Possesses depth of knowledge and practical application of budgeting, forecasting and resource management.
• Expert knowledge of project management principles and application.
• Demonstrates strong leadership skills.
• Strong financial acumen.
• Excellent judgment and decision making skills.
• Effective oral and written communication skills including the ability to communicate in English, both orally and in writing.
• Excellent interpersonal skills and problem solving ability.
• Effective organization and negotiation skills.
• Has successfully led national/international cross functional teams.
• Knowledge of regulatory guidelines and Directives.
• Skilled in process improvement, especially as it applies to clinical trials, clinical development and project management.
• Knowledge of medical therapeutic area and medical terminology.
• Computer skills

Education Required:

• Bachelor’s degree or higher in a scientific or healthcare discipline is required; Master’s degree preferred
• 7+ years’ experience in clinical research with at least 3 years’ experience in Project Management or Clinical Monitoring preferred. Prior experience participating in a Regulatory Authority inspection strongly preferred
• Documented training, knowledge and application of current GCP and ICH guidelines in clinical trials required
• Experience developing trial plans including site monitoring, risk mitigation strategies, trial budgets and site selection/feasibility as required
• Proficient written and verbal communication skills
• Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigator and site staff) using collaborative negotiation skills
• Therapeutic or medical knowledge preferred
• Regulatory authority inspection experience a plus

Other Skills

• Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
• Travel: up to 25%
• Ethics – Treats people with respect; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Job Types: Full-time, Contractual / Temporary
Contract length: 24 months

Salary: ₹35,000.00 – ₹50,000.00 per month

Benefits:

Schedule:

Supplemental pay types:

Experience:

• total work: 5 years (Required)

Application Deadline: 18/01/2023